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FDAOctober 17, 2024device

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

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

The hazard

Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)

What to do

FDA enforcement status: Ongoing

Brands named

roche diagnostics operationsrocheroche diagnostics

UPCs

0401563092997906542921190

Recall history

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

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