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Roche Diagnostics Operations, Inc. recalls Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quanti
Recalled October 23, 2019 · FDA recall Z-0152-2020 · Roche Diagnostics Operations
Hazard
Due to low Quality Control recovery and invalid Calibration. · FDA Class III
Units
7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Sold at
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.
Description
Due to low Quality Control recovery and invalid Calibration.
Product
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.
Manufacturer(s)
Roche Diagnostics Operations, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →