Magellan Diagnostics, Inc. Recalls
Showing 1-6 of 6 recalls
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results should be shared with the patient s physician for interpretation and to determine when retesting and follow-up care are necessary. - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available). - Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory. On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue. Immediate Actions: - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Promptly complete and return the Customer Notification Form below t
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Magellan issued a follow-on Recall notification related to the FDA Safety Notification dated May 17, 2017. This current recall follows FDAs recommendation to remove venous blood samples as an allowable sample type from all LeadCare products. This recall will supersede and replace the prior Recall notifications. Notifications issued by : UPS Letter (US), Registered Letter, E-mail, or Phone calls form May 23-May 25. Questions: Reba Daoust, Director of QA/RA 978-248-4811 or rdaoust@magellandx.com Refer to Firm's website: http://www.leadcare2.com/getmedia/2fd8a90f-5c64-4058-b6ab-5db13512f0fe/Letter-to-our-customers-5-17-17.pdf.aspx. The notification of May 2017 supercedes the firms previous communications:. Magellan Diagnostics, notified customers by letter dated Nov 29, 2014 and provided with the problem, mitigation action( customers have been advised to implement a minimum 24-hour incubation of the blood-treatment reagent mixture prior to analysis) . Customers were instructed to return a completed FaxBack form via fax to 978-600-1480. A revised letter issued May 1, 2017 recommending that customers make the following workflow changes: 1. Discontinue collecting blood samples for lead testing in Becton Dickinson (BD) EDTA Vacutainer tubes: Lavender and Tan tops. 2. Discontinue the 24 hour incubation for sample preparation. On 5/17/17 FDA issued News Release - FDA warns Americans about risk of inaccurate results from certain lead tests- manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults. Blood drawn from a vein may provide results that are lower than the actual level in the blood. FDA is warning laboratories not to use Magellan Diagnostic lead tests wit blood drawn from the vein. At this time all Leadcare systems can be used with blood drawn from a finger or heel stick. Based on FDA/s warning the firm issued notification letter to users on 5/xx/17.
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Magellan issued a Safety Notification letter from May 23-25, 2017 . The firm states following the FDA Safety Notice, published May 17, 2017, this notification is to advise your facility regarding a change to existing LeadCare product usage and labeling. Prior instructions for use included capillary and venous blood samples. However, because the LeadCare Testing Systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples, the FDA recommends discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus). Capillary samples may still be used on all LeadCare prducts listed above. Users requested to complete/sign Fax Form Record to verify that you have read and understood the Safety Communication to Customers on page 1. Contact Reba Daoust, Director of QA/RA 978-248-4811 or rdaoust@magellandx.com
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
An Urgent Medical Device Correction letter, dated January 9, 2018, was sent to customers. The letter identified the affected device and provided a description of the issue. If two of the four AA batteries are inserted incorrectly, the batteries may overheat, causing a minor burn if the user opens the battery compartment and tries to remove the hot batteries. Customers are to follow the steps outlined in the letter, including placing the enclosed label on the upper back panel of the analyzer to remind users who are changing batteries of the importance of correct placement. Proper battery placement should be provided in annual training. Customers are to complete and return the acknowledgement card. Please direct any questions to 800-275-0102 or LeadCareSupport@magellandx.com.
Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and treatment reagent of the test kit are specific for lead only. Contents of the LeadCare II Blood Lead Test Kit must only be used wit
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 g/dL). Results for patient testing with this lot will be displayed as HIGH.
The firm, Magellan, notified the Customers (end users) by telephone or email on August 8, 2018 to provide notification of the deficiency of the LeadCare II Blood Lead Test Kit having Lot Number 1808M. Replacement Buttons and an "URGENT MEDICAL DEVICE CORRECTION" letter dated August 9 2018 ( were shipped on August 9, 2018, for delivery on Friday, August 10, 2018.) The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Do NOT use the Yellow calibration button marked 1808M. 2. Discard the Yellow calibration button that came with the LeadCare II Test Kit Lot 1808M. 3. Place the new Blue calibration button with the test kit and use for controls and patient testing with Lot 1808M. 4. Inform your staff of the calibration button exchange. 5. Complete the fax form record included with this letter and fax to 978-600-1480 or email a scanned copy of the completed form to reply@magellandx.com. If you have questions, please contact us at 800-275-0102 or LeadCareSupport@magellandx.com.
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
LeadCare II Test Kits controls out of range
Magellan notified customers initially by Email, fax and/or verbal communication with Magellan Product Support representatives beginning on January 20, 2016 to advise of the problem and provide revised Assignment Control Value Matrix..