Safety Report: LeadCare® Test Kits - recalled due to underestimated blood lead levels, USA

United States

Company name: Meridian Bioscience, Inc.
Brand name: Meridian Bioscience, Inc.
Product recalled: LeadCare® Test Kits
Reason of the recall: LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
FDA Recall date: September 02, 2021
Recall details: Meridian Bioscience, Inc. (NASDAQ: VIVO), a provider of diagnostic testing solutions and life science raw materials, today announced its wholly owned subsidiary, Magellan Diagnostics, Inc. (“Magellan”), expanded the Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Plus® Blood Lead Test Kits, and LeadCare Ultra® Blood Lead Test Kits (the “LeadCare Test Kits”) for the detection of lead in whole blood.

Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range.  Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. 

In May 2021, Magellan initiated this voluntary recall after identifying an ongoing issue with testing of the controls included in the LeadCare Test Kits.  Magellan continues to investigate this issue and has conducted extensive testing to evaluate potential root causes.  

Scope of Recall: Magellan received reports that control tests of either the “Low-Control” (e.g., the “Level 1” control at approximately 9 g/dL ± 3g/dL) and/or the “High-Control” (e.g., the “Level 2” control at approximately 28 g/dL ± 4g/dL) generated a “low” result (i.e., “Control Out of Range-Low” [“COOR-L”]). 

Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples. As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall.  Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits (see list of affected lot numbers in the link below).

Magellan recommends the following:

- Customers should discontinue use of all LeadCare Test Kits lots identified as part of the recall and quarantine remaining inventory.
- Distributors should stop distribution of all LeadCare Test Kits lots identified as part of the recall, review current inventory and quarantine any remaining stock.
- Health Care Providers should evaluate patient test results that were generated with all recalled lots.
- Suspect results should be confirmed with an alternative lead testing option, such as those using Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory.
- See CDC’s recommended actions based on blood lead level
- Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter to FAX to (978) 600-1480. Complete this form even if you have no remaining inventory.
- After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product when available.

Product distribution has been paused until further notice and replacement product is currently unavailable. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan’s LeadCare® Product Support Team at 1-800-275-0102

Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/magellan-diagnostics-inc-expands-voluntary-recall-leadcarer-test-kits

Source: FDA