Albumin Gen.2 recall: Contamination
Albumin Gen.2, Catalog 05166861190
Why was Albumin Gen.2 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lots 43031001, 43718901
- Product
- Albumin Gen.2, Catalog 05166861190
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 11963
- Distribution
- Domestic distribution nationwide.
- Recall date
- October 21, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)