Roche Diagnostics Operations, Inc. recalls Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determina…

Recall date

September 11, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0153-2020

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

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.