Food, drugs, devices › Roche Diagnostics Corporation

Device recall: Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19*

FDA enforcement event 81859 · Class II · initiated 17 Dec 2018 · status Terminated · terminated 2 Nov 2020

DeviceVoluntary: Firm initiated3 product recordsIndianapolis, IN

Roche Diagnostics Corporation (Indianapolis, IN) initiated this device recall on 17 Dec 2018; FDA lists 3 product records under event 81859, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 2 Nov 2020. Initiation: voluntary: firm initiated. Roche Diagnostics Corporation has 26 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Roche Diagnostics Corporation, Indianapolis, IN.

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***"

Distribution

"US Nationwide distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1145-2019	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.	5292 analytical units	Class II	Terminated	24 Apr 2019
Z-1146-2019	Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, *added as of 5/10/19* 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.	5292 analytical units	Class II	Terminated	24 Apr 2019
Z-1147-2019	Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.	5292 analytical units	Class II	Terminated	24 Apr 2019

Context

92%of 2018 device events are Class II1,074 events that year

3product records in this eventfirm median: 1

26events on this register for the firm

Other enforcement events for Roche Diagnostics Corporation

Initiated	Product (first record)	Type	Class	Records
3 Jun 2019	The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form a	Device	Class II	1
4 Apr 2019	cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.	Device	Class III	2
18 Mar 2019	Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum an	Device	Class II	1
15 Mar 2019	cobas e 801 immunoassay analyzer	Device	Class II	1
4 Feb 2019	Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use	Device	Class II	1
17 Dec 2018	Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for	Device	Class II	1
14 Dec 2018	COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 0303	Device	Class II	2
24 Sep 2018	Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a	Device	Class II	1
13 Sep 2018	CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS	Device	Class I	1
16 Jul 2018	Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer con	Device	Class II	1

All 26 events for Roche Diagnostics Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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 risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.