FDA-Device2019-10-23Class III
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.
Roche Diagnostics Operations, Inc.
Hazard
Due to low Quality Control recovery and invalid Calibration.
Sold states
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.
Affected count
7,032 units (Expanded on 12/20/19 to include 29,696 additional units)
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2020Don't want to check this manually?
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