FDA MedWatch - LeadCare Test Kits by Magellan Diagnostics: Recall

Could potentially underestimate blood lead levels when processing patient blood samples

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: LeadCare Test Kits by Magellan Diagnostics: Recall - Could potentially underestimate blood lead levels when processing patient blood samples AUDIENCE: Health Professional, Patient, Risk Manager  ISSUE: Magellan Diagnostics 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 for the detection of lead in whole blood.  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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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 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.   RECOMMENDATIONS: 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: https://www.cdc.gov/nceh/lead/advisory/acclpp/actions-blls.htm Customers should discontinue use of all LeadCare Test Kits' lots identified as part of the recall and quarantine remaining inventory. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA