According to Magellan Diagnostics, Incorporated, a manufacturer of life science raw materials and medical diagnostic testing products, announced it is expanding the company’s Class I recall of its LeadCare® II Blood Lead Test Kits, LeadCare Ultra® Blood Lead Test Kits, and LeadCare Plus® Blood Lead Test Kits. The LeadCare Test Kits are being recalled due to the discovery of unacceptable levels of lead in whole blood.
Magellan Diagnostics, Incorporated, (“Magellan”) provides two test kit controls that are designed to simulate blood and are then spiked with lead (Pb) until reaching a distinct target value with an associated acceptable limit. The test kit results within the acceptable range show that the system is functioning properly prior to testing patient blood samples. Last May, Magellan Diagnostics, Incorporated, began a voluntary recall of these tests kits after finding recurring issues surrounding the testing of the controls included in Magellan’s LeadCare Test Kits. Magellan reported that it would continue to investigate this problem and has carried out “extensive testing to evaluate potential root causes.”
According to the recall, Magellan stated that it had received reports that control tests of either the “High-Control” and/or the “Low-Control” generated a “low” result error such as a “Control Out of Range-Low (COOR-L).” Magellan began the recall after finding the impacted LeadCare Test Kits lots might underestimate blood lead levels during the processing of patient blood samples.
Magellan has begun notifying distributors and customers affected by this LeadCare® recall. Moreover, Magellan’s customer recall notification gives instructions on returning and receiving a replacement of the recalled LeadCare Test Kits. Below is a list of the affected lot numbers.
70-6762 LeadCare® II Blood Lead Test Kit 2012M sub-lots 2013M, 2014M, 2015M, 2016M, 2017M, 2018M, 2101M, 2102M, 2103M, 2105M, 2106M, 2107M, 2109M, 2110M, 2111M, 2112M, 2113M, 2114M, 7114M, and 2115M.
70-8098 LeadCare Plus® Blood Lead Test Kit LeadCare Ultra® Blood Lead Test Kits 2011MU, 2104MU, and 2108MU.
Magellan is urging all customers to discontinue all LeadCare Test Kits lots as identified above and quarantine any remaining inventory. LeadCare Test Kit distributors have been advised to stop the distribution of LeadCare Test Kits lots that have been identified as part of the recall. The manufacturer also urges distributors to examine current inventory and quarantine any unused stock.
Health Care Providers are asked to re-evaluate patient test results that the recalled machine produced. Also, any suspect results should be verified with a secondary lead testing option, including “Inductively Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) at a high complexity, CLIA-certified, reference laboratory.”
The Centers for Disease Control and Prevention has posted recommended actions based on blood lead level.
Customers with recalled kits are asked to fill out and send in a Customer Notification Form. These recall forms are available on Magellan’s COOR-L recall webpage located here or email at [email protected]
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