Abbott Diabetes Care, Inc. Recalls
Showing 1-16 of 16 recalls
Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
On 11/14/19, Urgent Medical Device Correction notices were mailed to customers via overnight delivery. Customers were told to continue to use instructions for use regarding the cleaning of meters for use on single patients only. Customers were further asked to complete and return customer response forms. Customers with additional questions were encouraged to call customer service in 1-888-522-5226.
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can produc
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
The firm, Abbott Diabetes Care, sent an "IMPORTANT: URGENT PRODUCT RECALL"- letter dated February 14, 2014 to all customers for whom they have a record of receiving 0mV meters on February 19, 2014 via trackable method. Abbott also issued Press Release on March 14, 2014. The letter describe the product, problem and actions to be taken. The customers were instructed to discontinue use of your FreeStyle Flash or FreeStyle Blood Glucose Meter and call Abbott Diabetes Care Customer Service at 1-888-345-5364 for replacement at no charge; upon receiving replacement meter; immediately dispose of your old meter in accordance with your local and state disposal regulations; and please read your test strip insert carefully to ensure that you are using the correct test strip type for your Blood Glucose Meter. The firm, OmniPod, sent a ACD letter dated February 7, 2014 and included Abbotts February 14, 2014 letter to its customers. The letter described the product, problem, and actions to be taken. The customers were informed that you can safely continue to use the OmniPod System for your insulin delivery needs. The customers were instructed to read all of the materials included in the Abbott communication carefully and make sure you understand how it affects you; to immediately discontinue use of FreeStyle test strips with the Freestyle meter built into the OmniPod system; call Abbott Diabetes Care Customer Service immediately at 1-877-584-5159 for replacement strips; while waiting on replacement strips, use an unaffected meter such as the FreeStyle Freedom blood glucose meter; you can always use an alternative blood glucose meter. The notification will be posted on the Abbott Diabetes Care website at 222.abbottdiabetescare.com. If you have any further questions, please call Abbott Diabetes Care Customer Service at 1-877-584-5159. For questions or concerns with the continued use of your OmniPod Insulin Management System contact Insulet Product Support at 1-800-591-34
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Abbott Diabetes Care sent an Urgent Product Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take one of the following options immediately to address the issue. 1) Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. 2) Customers can contact Abbott Diabetes Care Customers Service at 1-866-723-2697 to expedite return and replacement of the affected product at no charge. For questions customers were instructed to call Abbott Diabetes Care Customers Service at 1-866-723-2697. For questions regarding this recall call 510-239-2775.
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle Blood Glucose test strip is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus
Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter built into the OmniPod system. Erroneously low results that are not recognized may pose significant risks to your health.
Abbott Diabetes Care sent an Urgent Product Recall letter in November 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who were affected were instructed to take the following steps: Call Abbott Diabetes Care Customers Service immediately at 1-888-736-9869 for replacement of the affected product. While waiting for replacement strips to arrive, use an alternate method to measure their blood glucose. If only test strips available to customers were from affected lots, customers should not stop testing their blood glucose. Customers were instructed to dispose of the test strips in accordance with their local and state disposal regulations. Customers with questions were instructed to call Abbott Diabetes Care Customers Service at 1-888-736-9869. For questions regarding this recall call 510-239-2775. Abbott issued a press release at the request of CDRH on november 27, 2013.
Abbott Diabetes Care Precision Xceed Pro Blood Glucose Test Strips
Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.
On 12/22/10, Abbott Diabetes Care notified customers via Press Release and letters explaining the reason for the recall and requesting the products be returned.
Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB SYSTEM KIT(ORANGE)PACK NAV, Abbott Item Number 70684-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.
Abbott FreeStyle Blood Glucose Monitoring System Test Strips for use with FreeStyle Blood Glucose Monitoring Meter
Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose results and to delay diabetes management, potentially leading to either hypo or hyperglycemia and their associated complications.
Recall initiated on April 24, 2008. An Urgent Medical Device Correction was issued to customers. Consignees were notified, along with registered users of the FreeStyle Freedom meters, via recall letters, visits or phone calls. Distributors will be notified, along with the creation of customer lists and tracking of communications to sub-recall. If you have any questions call Tina Mazurkiewicz at 1-800-777-6565.
Blood glucose meter, marketed with multiple brand names including: Precision Xtra New and Improved meter, Precision Xceed meter, Optium Xceed meter, Optium meter, ReliOn Ultima meter, Rite Aid meter, Kroger meter, Omron HEA-214 meter, Optium Xido meter, Boots meter.
Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to complete blanking of the numerical reading portion of the display.
Abbott sent Urgent Medical Device Correction letters, dated 31Aug07, to registered users/customers via FedEx or mail. The letter instructs users to verify that their display is correct, and if not, to discontinue use and call Abbott Customer Care at 1-877-844-4404 for a new meter. Warranty kits will have fliers added to them to alert users. Email and telephone contacts may be made as needed. U.S. consignees and registered users will be contacted by letter, telephone call or visit starting 23Aug07. Worldwide, customer lists will be created and communications tracked according to local requirements. Abbott issued a Press Release August 31, 2007 also.
FreeStyle Blood Glucose Monitoring System Test Strips and Freestyle Lite Blood Glucose Monitoring System Test Strips, for use with FreeStyle and FreeStyle Lite Test Strips respectively, 100 count, manufactured by Abbott Diabetes Care, Alameda, CA. Product is used with FreeStyle and FreeStyle Lite Blood Glucose Meters to measure glucose (sugar) in whole blood. The test strips are used for testing outside the body (in vitro diagnostic use). The FreeStyle Blood Glucose Monitoring Systems are inten
Product dispositioned for destruction was potentially diverted to end users.
The firm, Abbott Diabetes Care (ADC), will be posting notification on its Abbott Diabetes Care website. Also, the firm issued an "IMPORTANT: MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2009, to customers ( registered users of Free Style, Free Style Flash, FreeStyle Freedom or Free Style Navigator). For foreign consignees/customers, the firm has issued communication worldwide. The letter described the product, problem and action to be taken by the customers. The customers were instructed to please check the lot number on the test strip carton or vial for the affected product number; if found, discontinue use and call the ADC Customer Care line at: 1-800-310-1500 and the ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent. If you have any questions, please call ADC Customer Care line at 1-800-310-1500.
FreeStyle Connect Point of Care Blood Glucose Monitoring System, including Control Solutions and Test Strips; Part Number: 70672-01; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result.
On 2/17/06 the firm initiated the recall via its reps and on 2/22/06 notification was via letters explaining the reason for the recall and reporting that its reps will replace the units.
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02, manufactured by Abbott Diabetes Care, Inc., Alameda, CA. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels.
Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.
An "Important: Medical Device Notification" letter dated June 10, 2009 was issued to consignees. First consignees received notifications via letters to both direct consignees and registered customers of FreeStyle Lite and FreeStyle Freedom Lite blood glucose meter users in the states where the affected test strip lot was distributed. Affected accounts and customers were instructed to discontinue distribution and use of the product. The notification will be posted to the Abbott Diabetes Care website. Direct questions about the recall to Abbott Diabetes Care, Inc. by calling 510-749-5400.
Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3), (Version 2.4), (Version 2.5), and (Version 2.6); Serial Number(s): ALL;
If the time and date are not set correctly on both the user's meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software.
Firm initiated its recall on 12/21/2006. The firm provided customer letters with additional information (eg. flyer or insert) to customers that they had addresses for via fedex. In addition, the product notification was posted on the firm's internet website. Further, a flyer is to be included as a supplement to the user manual.
Abbott brand FreeStyle Navigator, Receiver Warranty Kit, Blood Glucose Monitoring System, Part Number: 70789-01. The product is manufactured by Benchmark Electronics, 3535 Technology Drive NW, Rochester, MN and distributed by Abbott Diabetes Care, 1360 South Loop Road, Alameda, CA.
The product has the Units of Measure set to mmol/L rather than mg/dL. The blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.
The Consignees of the affected FreeStyle Navigator Receiver Kit was contacted via telephone, Federal Express or an Abbott representative beginning on November 1, 2008. Contact Customer Service at 1-866-597-5520 with further questions.
Precision Xtra Blood Glucose monitoring system. Individual test meter and test strip kit.
The front button covers may detach from the meter.
The firm intends to send letters to all customers that have registered their units under the firm's warranty database and the firm's first consignees. In addition, this notification will be placed on the company website, with e-mail and phone contacts as needed. Letter dated March 5, 2007.
Abbott brand FreeStyle Blood Glucose Meter, distributed by Abbott Diabetes Care, 1420 Harbor Bay Pwky. Alameda, CA 94502. Manufactured by: Flextronics International, Long Jing Industrial Estate, Long Jing Road, Xi Li Town, Nantou District, Shenzhen, China
The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selectable unit of measure, and strip calibration code.
On 5/22/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions for the corrective actions.
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website. A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.