Reported Nov 15, 2023 · Ongoing
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of…
Magellan Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Magellan Diagnostics, Inc. · 101 Billerica Ave Bldg 4 · North Billerica, MA · 01862-1271
Is this the product you have?
- LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
- Lot codes and dates
- UDI-DI(01)00850355006000
- Lot Numbers
75 of 75 codes
22312231-102303M-112303M-122303M-132303M-152305M-012305M-022305M-032305M-042305M-052306M-012306M-022306M-032306M-042306M-052306M-062307M2307M-042307M-052307M-062307M-072307M-102307M-112308M-012308M-022308M-032308M-072309M2310M-012310M-032310M-042310M-052310M-062310M-082311M-022311M-032311M-052311M-092311M-102312M2312M-012312M-042312M-052312M-072313M2313M-012313M-052313M-072314M-062314M-072314M-082314M-092314M-122314M-132315M-022315M-032315M-042315M-052315M-06
- Amount recalled
- 11,442 LeadCare II kits (549,216 tests)
Where it was sold
- Nationwide
Why it was recalled
During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).
This product could cause temporary or reversible health problems — stop using it.
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