Alere San Diego Recalls
Showing 1-8 of 8 recalls
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.
Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verification form. A previous notice from Alere sent in November 2010 instructs users to contact Alere to receive the ROM pack upgrade. Customers may email LDXROM@alere.com to request an electronic form to complete and return via email. Customers can expect their ROM packs approximately 10 to 14 business days after Alere receives their request. If customers have transferred ownership to another party, they can email Alere at LDXROM@alere.com with the updated contact information. If customers are not currently using their Cholestech LDX System, it is recommended that the ROM Pack upgrade be installed prior to restarting use of any Cholestech LDX analyzer. Customers with questions regarding this communication can call Alere at (877) 441-7440, option 1 or email at LDXROM@alere.com.
Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abuse Panel Plus TCA (K973784), & Triage Drugs of Abuse Panel Plus PPX (K014247) Model Number: 90008, 92002, & 92000 Type of Packaging (i.e. box, plastic bag): For all affected device types: 25 individually pouched devices in a labeled kit box. The Triage Drugs of Abuse Panel plus Tricyclic Antidepressants utilizes a patented immunochemistry, ASCENDTM MULTIMMUNOASSAY (AMIATM). Each AMIATM assay is a competiti
Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.
Alere sent a "PRODUCT NOTIFICATION" letter dated January 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return to the firm. Contact Technical Services at 1-877-308-8287.
Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of congestive heart failure, an aid in the risk stratification of patients with heart failure, and as an aid in the risk stratification of patients with acute coronary syndromes.
Alere San Diego, Inc. is initiating a voluntary recall of the Alere Triage CardioProfiler Panel PN 9700CP, Lot W49569 and the Alere Triage Profiler SOB Panel PN 97300, Lot W48990. Alere San Diego, Inc. has determined that these lots have an increased frequency of Troponin I results >0.05ng/mL for samples which are found to be below 0.05ng/mL upon additional testing.
A recall communication was initiated on 3/15/12 with Alere San Diego, Inc. forwarding a "Urgent Medical Device Recall" letter to all their customers who purchased the Alere Triage CardioProfiler Panel PN 97100CP, Lot W49569 and Alere Triage Profiler SOB Panel PN 97300, Lot W48990. The letter informed the customers about the problems identified and the actions to be taken. Customers with any questions about the information contained in this notification should contact Alere San Diego, Inc. at (877) 308-8287.
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25);
Alere San Diego is expanding the scope of the voluntary recall of the Strep A Rapid Test Cassette and Twist devices from the single lot that was recalled in January 12, 2011 to all lots of product that were on the market within the expiry period.
The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 1, 2011 to its customers. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to retain the recall letter for their records as documentation that they have received the recall information. Customers were instructed to follow the directions and return the attached Verification Form. Customers were instructed to use the table in the Verification Form to document all inventory at any of their inventory locations. Customers may use multiple forms to document all sites, products, and lots. Alere will issue credit against PO#ASD811STA for any unused portion of the product based on completion and return of the attached Verification Form. Customers with any technical questions about the information contained in the notification were instructed to contact Alere by phone (877) 866-5309, fax (877) 866-9304 or email: ca2services@Alere.com.
Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricyclic Antidepressants in urine.
The recall was initiated because Alere San Diego has confirmed false positive THC results obtained on Triage Drugs of Abuse Plus TCA 25 devices from lots 235991 and 238928.
A recall communication was initiated on July 1, 2011 with Alere San Diego forwarding a Product Notification and a Verification Form (via fax, e-mail or direct mail) to all their customers who purchased the Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 9200, Lots 235991 and 238928. The letter provides the customers with an explanation of the problem identified and an action to be taken. The firm reminds customers that clinical consideration and professional judgment must be applied to any test result. Customers were instructed to retain the Product Notification letter for their records as documentation that they have received the information and to ensure that all users have a copy. Alere will replace the lots at the customer's request. As the customers complete the fax back form, they were instructed to indicate whether they wish to replace the affected product. Customers were instructed to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice. If customers have any further questions or need to report any concerns they have about the Triage Drugs of Abuse Plus TCA performance, they were instructed to contact Technical Services at (877) 308-8287 or by e-mail at techservice@alere.com.
Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.
Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers. The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere. For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.
PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio Starter Kit Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere INRatio2 PT/INR Home Monitoring
Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.
Alere sent a recall notification letter dated October 6, 2011, and Verification Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an alternate prep pad that is not involved with the PDI recall, or use a sterile gauze pad with isopropyl alcohol. If customers purchase alcohol pads from a store or pharmacy, customers can confirm with their pharmacist that the pads they are purchasing are not associated with the PDI recall. INRatio/INRatio2 kits at Alere are currently being reworked to include a sterile PDI alcohol pad. Customers were instructed to complete and FAX the enclosed Verification Form within 10 days to confirm their receipt of the notice and to indicate the number of discarded/required replacement alcohol prep pads. Customers with questions about INRatio/ INRatio 2 were instructed to consult their healthcare provider, or call Alere Technical Service at 877-866-5313 (24 hours a day, 7 days a week).
0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/lNR Testing Kit, Self-Test System; 0100007, Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombinme/lNR Testing Kit, Self- Test System; 0100072, Alcohol Prep Pads, packaged in the INRatio Starter Kit
The recall of the Triad Group alcohol prep products is due to potential contamination of these products with the bacteria Bacillus cereus, which could lead to life-threatening infections.
Alere sent a CUSTOMER NOTIFICATION letter on February 28, 2011 to all affected custumers. The letter included; description of product, affected lots, statement of potential for contamination which could lead to life-threatening infections. Alere asked its customers to discard the Triad Alcohol Prep Pads provided and complete and FAX the enclosed Verification Form within 10 days to confirm receipt of notice and to indicate the number of discarded/required replacement alcohol prep pads. The letter instructed customers to call Alere Technical Services for additional information at 888-246-7483.