Tina-quant D-Dimer Test System recall
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400…
Why was Tina-quant D-Dimer Test System recalled?
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
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?
All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
- Product
- Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400…
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 5,263 kits
- Distribution
- US Nationwide distribution.
- Recall date
- November 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)