Roche Diagnostics Operations, Inc. recalls Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quanti…
- Recall date
- September 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0152-2020
- FDA classification
- Class III
- Brand / firm
- Roche Diagnostics Operations, Inc.
- Sold / distributed
- US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
Why it was recalled
Due to low Quality Control recovery and invalid Calibration.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
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