Recall Z-0103-2021 ยท DBI Complement C4, Antigen, Antiserum, Control
Roche Diagnostics Operations, Inc.
Tina-quant Complement C4 ver.2, Catalog 05991994190
| Date | Aug 27, 2020 |
| Status | Terminated |
| Reason | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was observed and is the result of cross contamination between the R1 and R3 reagents. |
| Root cause | Under Investigation by firm |
| Action | On August 27, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that this was an expansion of the previous notification sent on September 11, 2019, as new products and lots had been added to the scope of the recall. Customers were asked to do the following: " Discontinue use and discard any remaining affected product in your inventory according to your local waste guidelines. " Refer to the Product Replacement section of the letter for product replacement information. " Complete all sections of the enclosed fax back form and fa |
| Quantity | 180 units |
| Distribution | Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012359 | TINA-QUANT COMPLEMENT C4 TEST SYSTEM Roche Diagnostics Corp., Nov 29, 2001 |