Roche Diagnostics Operations, Inc.: Device Recall
Recall #Z-0489-2025 · 10/17/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0489-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Status
- Ongoing
- Date Initiated
- 10/17/2024
- Location
- Indianapolis, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 458 units
Reason for Recall
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Product Description
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Distribution Pattern
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Other Recalls by Roche Diagnostics Operations, Inc.
- Class II: Risk 11/21/2025
- Class II: Risk 08/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.