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Device recall: cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a

FDA enforcement event 79676 · Class II · initiated 22 Feb 2018 · status Terminated · terminated 15 Nov 2019

DeviceVoluntary: Firm initiated4 product recordsIndianapolis, IN

Roche Diagnostics Corporation (Indianapolis, IN) initiated this device recall on 22 Feb 2018; FDA lists 4 product records under event 79676, 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 15 Nov 2019. 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

"The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate."

Distribution

"USA ( nationwide)"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1610-2018	cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total…	1026 total products	Class II	Terminated	9 May 2018
Z-1611-2018	Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total…	1026 total products	Class II	Terminated	9 May 2018
Z-1612-2018	cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total…	1026 total products	Class II	Terminated	9 May 2018
Z-1613-2018	cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total…	1026 total products	Class II	Terminated	9 May 2018

Context

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

4product 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	Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 **added as of 5/10/19	Device	Class II	3
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

All 26 events for Roche Diagnostics Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate."

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: "USA ( nationwide)"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 15 Nov 2019. "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.