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FDASeptember 14, 2015device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

biochemical diagnosticsbiochemical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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