Device product
Tina-quant Complement C4 ver.2, Catalog 05991994190
Z-0103-2021
Product summary
- Event
- Event 86406
- Status
- Terminated
- Classification
- Class III
- Quantity
- 180 units
- Official record key
device-enforcement:Z-0103-2021
Official wording
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.
Code information: lot 36870301
Distribution pattern: Domestic distribution nationwide.
Derived failure modes
-
Unknown
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.