Roche Molecular Systems, Inc.: FDA recalls

FDA enforcement reports name Roche Molecular Systems, Inc. as the recalling firm in 30 events. The events have 42 product records. The recalls started from 2012 to 2022. All the events are device recalls.

See the 30 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

30 events, newest first.

FDA enforcement events of Roche Molecular Systems, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
21 Dec 2022	cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190	Device	Class II	3	Ongoing
8 Sep 2022	cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.	Device	Class II	1	Terminated
16 Nov 2021	cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190	Device	Class II	1	Ongoing
3 Sep 2021	cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190	Device	Class II	1	Ongoing
4 Aug 2021	cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190	Device	Class II	1	Terminated
25 Mar 2021	cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190	Device	Class II	2	Ongoing
23 Nov 2020	uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001	Device	Class II	1	Terminated
19 Nov 2020	The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system.…	Device	Class II	1	Terminated
3 Jun 2020	MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.	Device	Class II	1	Terminated
2 May 2018	MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to…	Device	Class II	1	Terminated
27 Oct 2017	Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.	Device	Class II	1	Terminated
16 Nov 2016	LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC…	Device	Class II	1	Terminated
17 May 2016	cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.	Device	Class III	1	Terminated
9 May 2016	cobas Liat Analyzer	Device	Class II	1	Terminated
5 Apr 2016	cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor…	Device	Class II	1	Terminated
15 Mar 2016	cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use	Device	Class II	1	Terminated
3 Mar 2016	Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems	Device	Class II	1	Terminated
24 Jul 2015	cobas Liat Analyzer, for in vitro diagnostic use.	Device	Class II	1	Terminated
13 Jan 2015	cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay	Device	Class III	1	Terminated
18 Dec 2014	cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.	Device	Class III	1	Terminated
6 Jan 2014	cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing…	Device	Class II	1	Terminated
25 Jul 2013	KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The…	Device	Class II	1	Terminated
1 Apr 2013	cobas 4800 system –z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.	Device	Class II	1	Terminated
28 Nov 2012	COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.	Device	Class II	1	Terminated
11 Oct 2012	COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland	Device	Class II	1	Terminated
31 Jul 2012	cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as…	Device	Class III	1	Terminated
16 Jul 2012	Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain…	Device	Class II	10	Terminated
23 Apr 2012	Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.	Device	Class II	1	Terminated
24 Feb 2012	Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human…	Device	Class III	1	Terminated
1 Feb 2012	COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Type and class

Roche Molecular Systems, Inc.: events for each product type
Type		Events
Device		30

Roche Molecular Systems, Inc.: events in each class
Class		Events
Class II		25
Class III		5

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 4

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Roche Molecular Systems, Inc., by the year that the recall started. The largest year is 2012, with 7 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Roche Molecular Systems, Inc.: FDA recalls. https://recallregister.com/firm/roche-molecular-systems-inc/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: NJ

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Roche Molecular Systems, Inc. have?: Class II: 25 events. Class III: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Roche Molecular Systems, Inc.?: FDA event 91482, which the firm started on 21 Dec 2022. The first product in the record is: cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
How many FDA recalls of Roche Molecular Systems, Inc. have the status Ongoing?: 4 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.