FDA-Device2020-10-21Class III
Albumin Gen.2, Catalog 05166861190
Roche Diagnostics Operations, Inc.
Hazard
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.
Sold states
Domestic distribution nationwide.
Affected count
11963
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
Albumin Gen.2, Catalog 05166861190
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0104-2021Don't want to check this manually?
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