FDA Device recall Z-0634-2021
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human se…
- FDA Device
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human se… by Roche Diagnostics Operations, citing roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discolo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0634-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-06 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
Reason
Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the Tina-quant C-Reactive Protein Gen. 3 on the cobas c701 and 702 modules. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents.
Identifiers
| code_info | CRPL3 - lot 42402301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Roche Diagnostics Operations
- cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU,…
FDA Device · Class II · 2026-03-11 · Roche Diagnostics Operations - The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminesce…
FDA Device · Class II · 2026-01-14 · Roche Diagnostics Operations - cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocystei…
FDA Device · Class II · 2024-11-27 · Roche Diagnostics Operations - Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine ki…
FDA Device · Class II · 2024-10-02 · Roche Diagnostics Operations - Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502
FDA Device · Class II · 2023-11-29 · Roche Diagnostics Operations
All Roche Diagnostics Operations recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0634-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.