Roche Diagnostics Operations, Inc. recalls cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test fo…
- Recall date
- October 17, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0489-2025
- FDA classification
- Class II
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Why it was recalled
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
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