FDAFDA · Food and drugs·Recall number Z-0489-2025
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Published November 27, 2024 · Recall initiated: October 17, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
- Lot
- UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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