Z-0104-2021 Class III Terminated
FDA device recall Z-0104-2021 was initiated by Roche Diagnostics Operations, Inc. on August 27, 2020 and is designated Class III. 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 contam… The recall status is terminated (terminated May 22, 2024). Affected quantity: 11963.
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
- 11963
Product Description
Albumin Gen.2, Catalog 05166861190
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
lots 43031001, 43718901