Magellan Diagnostics is recalling its LeadCare II, LeadCare Plus, and LeadCare Extremely Blood lead checks resulting from a major threat of falsely low outcomes. The Meals and Drug Administration (FDA) has designated this as a Class I recall, probably the most critical sort.
The LeadCare II, LeadCare Plus, and LeadCare Extremely Blood lead checks use a finger or heel stick complete blood pattern to find out a person’s blood lead degree. The LeadCare techniques are utilized in medical laboratories, doctor’s workplaces, clinics, and hospitals within the US.
The FDA is anxious that getting falsely low take a look at outcomes might result in inappropriate follow-up assessments, which can end in affected person hurt. The recalled merchandise have been distributed between October 27, 2020 and June 15, 2021 and embody the next lot codes:
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- LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M.
- LeadCare Plus and LeadCare Extremely: 2011MU, 2104MU, and 2108MU.
Right now, the Firm experiences that the next 3 a lot of LeadCare II take a look at kits are not impacted by this recall: 2012M, 2018M, and 2102M.
It is strongly recommended that use of all affected take a look at package tons be discontinued and any take a look at outcomes which can be unclear ought to be confirmed with an alternate lead testing choice. Youngsters who have been examined with the recalled LeadCare take a look at kits whose outcomes have been lower than 5µg/dL ought to be retested with a venous blood pattern analyzed with larger complexity testing. Youngsters also needs to be retested in the event that they have been examined with a LeadCare take a look at package with an unknown lot quantity between October 27, 2020 and July 6, 2021.
Based on the Facilities for Illness Management and Prevention, precedence for retesting ought to be given to (1) youngsters the place there’s medical concern that signs or developmental issues could also be associated to steer publicity; (2) populations at larger threat of elevated blood lead ranges, similar to youngsters examined resulting from Medicaid-required screening or resulting from different state or native necessities; and (3) people who’re pregnant or breastfeeding.
Hostile occasions associated to this recall ought to be reported to the FDA’s MedWatch Program. Extra details about the recall might be obtained by calling (800) 275-0102 or emailing [email protected].
References
- Recall of LeadCare® Blood Lead Exams resulting from threat of falsely low outcomes. US Facilities for Illness Management and Prevention. Accessed July 6, 2021. https://emergency.cdc.gov/han/2021/han00445.asp?ACSTrackingID=USCDC_511-DM60951&ACSTrackingLabel=HANpercent20445percent20-%20Generalpercent20Public&deliveryName=USCDC_511-DM60951.
- Magellan Diagnostics recollects LeadCare II, LeadCare Plus, and LeadCare Extremely Blood Lead Exams resulting from threat of falsely low outcomes. [press release]. Silver Spring, MD: US Meals and Drug Administration; July 1, 2021.
This text initially appeared on MPR