cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Reported: November 27, 2024 Initiated: October 17, 2024 #Z-0489-2025
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
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)
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 458 units
- Distribution
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 458 units.
Why was this product recalled? ▼
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2024. Severity: Moderate. Recall number: Z-0489-2025.
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