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Recall Observatory FDA recall evidence

Device product

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.

Z-0153-2020

September 11, 2019

Class III

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83806
Status
Terminated
Classification
Class III
Quantity
2,304 units
Official record key
device-enforcement:Z-0153-2020

Official wording

Reason: Due to low Quality Control recovery and invalid Calibration.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to low Quality Control recovery and invalid Calibration.