Z-0103-2021 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 21, 2020
- Initiation Date
- August 27, 2020
- Termination Date
- May 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180 units
Product Description
Tina-quant Complement C4 ver.2, Catalog 05991994190
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide.
Code Information
lot 36870301