Recall archive / FDA device enforcement
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test ... — FDA record Z-0489-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Reason
- Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
- Classification
- Class II
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 458 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0489-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 17, 2024
- Center classification date
- Nov 19, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.