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Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for
Recalled November 27, 2024 · FDA recall Z-0489-2025 · Roche Diagnostics Operations
Hazard
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias) · FDA Class II
Units
458 units
Sold at
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Description
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →