Tina-quant D-Dimer 08105618190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 3, 2023Open, Classified
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Z-0352-2024 · Root cause: Under Investigation by firm · FDA record ↗
Other FIBRIN SPLIT PRODUCTS devices
- Tina-quant D-Dimer 3001245322Roche Diagnostics GmbH · FIBRIN SPLIT PRODUCTS1 recall2 reports
- AU OSR60135Beckman Coulter, Inc. · Fibrin Split Products1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.