Reported Nov 29, 2023 · Ongoing
Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
Tina-quant D-Dimer Test SystemFibrinogen/Fibrin Degradation Products AssayMaterial Numbers 03001245322 - (cobas c 311501 and 502INTEGRA 400 plus)08105618190 - (cobas c 303 and 503)
- Lot codes and dates
- All Lots Affected
- UDI
04015630914593 - (cobas c 311501 and 502
- INTEGRA 400 plus) UDI07613336133651 - (cobas c 303 and 503)
- Amount recalled
- 5,263 kits
Where it was sold
- Nationwide
Why it was recalled
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
This product could cause temporary or reversible health problems — stop using it.
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