Magellan Diagnostics is recalling its LeadCare II, LeadCare Plus, and LeadCare Extremely Blood lead exams attributable to a major danger of falsely low outcomes. The Meals and Drug Administration (FDA) has designated this as a Class I recall, probably the most severe sort.
The LeadCare II, LeadCare Plus, and LeadCare Extremely Blood lead exams use a finger or heel stick entire blood pattern to find out a person’s blood lead stage. The LeadCare programs are utilized in medical laboratories, doctor’s places of work, 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.
At the moment, the Firm studies that the next 3 a number 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 equipment heaps be discontinued and any take a look at outcomes which can be unclear ought to be confirmed with an alternate lead testing possibility. Kids 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 increased complexity testing. Kids must also be retested in the event that they have been examined with a LeadCare take a look at equipment with an unknown lot quantity between October 27, 2020 and July 6, 2021.
In line with the Facilities for Illness Management and Prevention, precedence for retesting ought to be given to (1) youngsters the place there may be medical concern that signs or developmental issues could also be associated to guide publicity; (2) populations at increased danger of elevated blood lead ranges, reminiscent of youngsters examined attributable to Medicaid-required screening or attributable to 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 may be obtained by calling (800) 275-0102 or emailing [email protected].
References
- Recall of LeadCare® Blood Lead Assessments attributable to danger 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 remembers LeadCare II, LeadCare Plus, and LeadCare Extremely Blood Lead Assessments attributable to danger of falsely low outcomes. [press release]. Silver Spring, MD: US Meals and Drug Administration; July 1, 2021.
This text initially appeared on MPR