Z-0153-2020Class III

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 -

Name: Z-0153-2020 Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 -
Creator: Roche Diagnostics Operations, Inc.
Published: 2019-09-11
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2019-09-11 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2019-09-11. FDA classified it as Class III and gives the reason as "Due to low Quality Control recovery and invalid Calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0153-2020
Classification: Class III
Status: Terminated
Initiated: 2019-09-11
Posted: 2019-10-16
Terminated: 2024-06-11
Recalling firm: Roche Diagnostics GmbH
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.
Product code: CIG Diazo Colorimetry, Bilirubin
Reason for recall: Due to low Quality Control recovery and invalid Calibration.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 1. Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. 2. Complete and fax or email the form even if you are not requesting product replacement. Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC. An Urgent Medical Device Correction letter dated 12/18/19 was sent to customers regarding the expansion of the recall to include an additional lot of Albumin Gen.2 Reagent. Actions Required " Discontinue use and discard the remaining affected product in your inventory according to your local waste guidelines. " Complete the attached fax form (TP-00848) and fax or email it according to the instructions on the form even if you are not requesting product replacement. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Quantity in commerce: 2,304 units
Distribution: 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.
Product codes and lots: Lot # 36133801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2020	Class III	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16
Z-0153-2020	Class III	Terminated	Voluntary: Firm initiated	2019-10-23	2019-10-16

Product code CIG

K131544Class IICobas C Bilirubin Total Gen.3Roche Diagnostics / cleared 2013-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)