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Biochemical Diagnostics Inc recalls CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Contr
Recalled December 2, 2015 · FDA recall Z-0328-2016 · Biochemical Diagnostics
Hazard
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. · FDA Class III
Units
Domestic: 4,473 kits
Sold at
US Nationwide Distribution
Description
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Product
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Manufacturer(s)
Biochemical Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →