- Company Announcement Date:
- September 01, 2021
- FDA Publish Date:
- September 02, 2021
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason Description
LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples
- Company Name:
- Meridian Bioscience, Inc.
- Brand Name:
Meridian Bioscience, Inc.
- Product Description:
LeadCare® Test Kits
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 below).
|70-6762||LeadCare® II Blood Lead Test Kit||2012M sub-lots***||Apr 8, 2022|
|2013M*||Apr 22, 2022|
|2014M*||Apr 29, 2022|
|2015M*||May 12, 2022|
|2016M*||May 19, 2022|
|2017M*||Jun 10, 2022|
|2018M||Jun 6, 2022|
|2101M**||Jul 28, 2022|
|2102M||Sept 30, 2021|
|2103M**||Aug 18, 2022|
|2105M**||Sep 11, 2022|
|2106M**||Jan 21, 2022|
|2107M**||Sept 30, 2022|
|2109M||Oct 15, 2022|
|2110M||Oct 29, 2022|
|2111M||May 31, 2022|
|2112M||Nov 13, 2022|
|2113M||Jun 30, 2022|
|2114M||Dec 17, 2022|
|7114M||Dec 17, 2022|
|2115M||Dec 29, 2022|
|LeadCare Plus® Blood Lead Test Kit LeadCare Ultra® Blood Lead Test Kit||2011MU*||Mar 25, 2022|
|2104MU**||Aug 25, 2022|
|2108MU**||Mar 31, 2022|
* Lots previously included in the recall initiated on May 7, 2021
** Lots previously included in the recall initiated on June 11, 2021
*** Only the following sub-lots of lot 2012M are included in the recall: -08, -09, -10, -11, -12, -13, and -14
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 [email protected] or FAX to (978) 600-1480. Complete this form even if you have no remaining inventory. These forms are also available on Magellan’s COOR-L recall webpage: https://www.magellandx.com/resources/leadcare-test-kit-controls-out-of-range-low-coor-lo-recall/
- 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, or email at [email protected].
The U.S. Food and Drug Administration (“FDA”) has been notified of this recall.
FDA MedWatch Reporting
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
Vice President – Investor Relations Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: [email protected]