Device product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Z-0489-2025
Product summary
- Event
- Event 95609
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 458 units
- Official record key
device-enforcement:Z-0489-2025
Official wording
Reason: Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Code information: UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Distribution pattern: US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Derived failure modes
-
Unknown
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)