Z-1145-2019Class II

Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as...

Name: Z-1145-2019 Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as...
Creator: Roche Diagnostics Corporation
Published: 2018-12-17
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-12-17 / Terminated / root cause: design

FDA source

Roche Diagnostics Corporation began a recall of Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product... on 2018-12-17. FDA classified it as Class II and gives the reason as "New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1145-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-17
Posted: 2019-04-13
Terminated: 2020-11-02
Recalling firm: Roche Diagnostics GmbH
Product: Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitative determination of 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: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
Root cause tag: design
FDA root cause: Device Design
Action: On 12/17/18, the firm distributed an Urgent Medical Device Correction letter to affected consignees. Customers were notified of the interference issues. The Limitations-interference section of the method sheets for the cobas c 311 analyzer and the cobas c 501, 502, 701, and 702 modules are being updated with the following claims: Bilirubin Total Gen.3 assay: Immunoglobulins: No significant interference from immunoglobulins up to a concentration of 28 g/L (187 mol/L) (simulated by human immunogloblulin G). Lactate Gen.2 assay (CSF samples): Ditaurobilirubin: No significant interference from ditaurobilirubin up to an approximate concentration of 102 mol/L (6 mg/dL). Tina-quant IGM-2 (Sensitive application): Hemolysis: No significant interference up to an H index of 600 (approximate hemoglobin concentration of 373 mol/L or 600 mg/dL). Lipemia (Intralipid): No significant interference up to an L index of 600 Customers were asked to do the following: " Be aware of the new interference claims listed in this Urgent Medical Device Correction (UMDC). This UMDC serves as labeling until the updated method sheets are available. The method sheets for the MODULAR ANALYTICS P/D modules will not be updated. " Manually update the H and L indexes for the IGMP2 sensitive application on your cobas c 311 analyzer or cobas c 501, 502, 701, and 702 modules following the instructions provided in this UMDC. " Complete all sections of the enclosed fax form (TP-00507) and fax it to 1-xxx-xxx-xxx or email it to [email protected]. " File this UMDC for future reference. When the method sheets are updated, they will be available on the diagnostics.roche.com 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. website and on the cobas e-library. ***UPDATE: Firm sent updated communication to customers dated 5/9/2019 informing them that L and H index values
Quantity in commerce: 5292 analytical units
Distribution: US Nationwide distribution.
Product codes and lots: n/a

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1145-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1145-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13
Z-1146-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13
Z-1147-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-24	2019-04-13

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)