FDA Medical devices recall ·
cobas HCYS, Homocysteine Enzymatic Assay, Material Number recall
- Recall number
- Z-0489-2025
- Date
- (initiated October 17, 2024)
- Company / brand
- Roche Diagnostics Operations, Inc.
9115 Hague Rd, Indianapolis, IN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 458 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Why was it recalled?
Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneous patient results (positive or negative bias)
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
Distribution
US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
States: Florida Iowa Indiana New Jersey New York Oklahoma South Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0489-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.