FDA Enforcement
Class II
Ongoing
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Recall: Z-0489-2025
·
Reported November 27, 2024
Enforcement
- Recall Number
- Z-0489-2025
- Event ID
- 95609
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2024
- Initiation Date
- October 17, 2024
- Classification Date
- November 19, 2024
- Address
- 9115 Hague Rd, N/A, Indianapolis, IN, 46256-1025, United States
Description
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)
Code Info
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Distribution
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
Quantity
458 units