Roche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
Roche is recalling Tina-quant D-Dimer Test System kits because they produce elevated results when used with lithium-heparin plasma samples, potentially affecting diagnostic accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a clinical laboratory diagnostic device. Although no hospitalizations, illnesses, or injuries are reported, the inaccurate test measurements represent a risk-of-harm product where measurement errors could affect patient diagnoses and treatment decisions.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 5,263 kits of the Tina-quant D-Dimer Test System, an in vitro clinical laboratory diagnostic assay for measuring D-Dimer and Fibrinogen/Fibrin Degradation Products. All lot numbers are affected, and the product was distributed nationwide in the United States.
The recall was initiated because the test system produces elevated results when used with lithium-heparin plasma samples compared to results from citrated plasma samples. This measurement discrepancy could compromise the accuracy of diagnostic test results and affect patient care decisions.
The affected Material Numbers are 03001245322 (for cobas c 311, 501, and 502 analyzers and INTEGRA 400 plus) and 08105618190 (for cobas c 303 and 503 analyzers). Laboratories using this test system should contact Roche Diagnostics Operations, Inc. for guidance.
The recalled product
- Product
- Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 5,263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All Lots Affected. UDI: 04015630914593 - (cobas c 311
- 501 and 502
- INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
Distribution
Distributed nationwide across the United States.
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