Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0153-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: September 11, 2019

Date Posted: October 23, 2019

Recall Number: Z-0153-2020

Event ID: 83806

Reason for Recall:

Due to low Quality Control recovery and invalid Calibration.

Status: Terminated

Product Quantity: 2,304 units

Code Information:

Lot # 36133801

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated