cobas HCYS recall
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 cobas HCYS 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 04015630929979, Lot Number 747029, exp. 30-SEPT-2024
- Product
- cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 458 units
- Distribution
- US: NJ, TX, NY, FL, IN, TX, OK, SC, IA,
- Recall date
- November 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)