Recall Z-0634-2021 ยท DCN System, Test, C-Reactive Protein
Roche Diagnostics Operations, Inc.
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.
| Date | Nov 6, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On November 6, 2020, the firm mailed customers Urgent Medical Device Correction letters. Customers were informed that the present communication serves as an update to previous UMDCs sent on 9/11/2019, 12/18/2019, and 8/27/2020, in that it includes the new product and lot number listed above. Customer Instructions: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section on page 2 of the UMDC for product replacement information. " Complete all sections of the enclosed faxback form (TP-01 |
| Quantity | 699 units |
| Distribution | US Nationwide distribution including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083444 | C-REACTIVE PROTEIN (LATEX) Roche Diagnostics Corp., Mar 18, 2009 |