Branchburg, NJ, United States
Roche Molecular Systems, Inc. recalls
11 recalls recorded since 2018, most recently on 21 December 2022. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls11
Ongoing (FDA)4
Terminated or completed7
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 December 2022
- Reason
- The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1105-2023, Z-1106-2023, Z-1104-2023
- cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
- cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
- cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
Terminated Class II Medical devices
- Recall started
- 8 September 2022
- Terminated
- 7 November 2024
- Reason
- Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
- Distribution
- International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0097-2023
- cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Ongoing Class II Medical devices
- Recall started
- 16 November 2021
- Reason
- Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0828-2022
- cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Ongoing Class II Medical devices
- Recall started
- 3 September 2021
- Reason
- False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, UK, Poland, Spain, Italy, Sweden, Greece, Denmark, Norway, Netherlands, France, Czech Republic, Belgium, Austria, Slovakia, Hungary, Switzerland, Lithuania, Slovenia. Serbia, North Macedonia, Myanmar, Lebanon, Russia, C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0083-2022
- cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Terminated Class II Medical devices
- Recall started
- 4 August 2021
- Terminated
- 23 February 2024
- Reason
- Customers have reported an increased number of false positive SARS-CoV-2 results.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2498-2021
- cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Ongoing Class II Medical devices
- Recall started
- 25 March 2021
- Reason
- Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
- Distribution
- Nationwide WorldWide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1414-2021, Z-1413-2021
- cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- 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
Terminated Class II Medical devices
- Recall started
- 23 November 2020
- Terminated
- 22 May 2023
- Reason
- When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications.
- Distribution
- Domestic distribution to Maryland and Michigan. International distribution to France, Greece, Italy, Poland, Turkey, Brazil, India, and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0877-2021
- uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Terminated Class II Medical devices
- Recall started
- 19 November 2020
- Terminated
- 10 August 2023
- Reason
- Dirty Lens May Cause Invalid or False Positive Results
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Germany, Italy, Spain, United Kingdom, France, Austria, Turkey, Belgium, Poland, Portugal, Greece, Netherlands, Switzerland, Czech Republic, Romania, Sweden, Norway, Denmark, Hungary, Ireland, Slovakia, Croatia, Bulgari
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0846-2021
- 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 screenin
Terminated Class II Medical devices
- Recall started
- 3 June 2020
- Terminated
- 4 October 2023
- Reason
- When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results.
- Distribution
- Worldwide distribution - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2551-2020
- 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
Terminated Class II Medical devices
- Recall started
- 2 May 2018
- Terminated
- 30 April 2019
- Reason
- Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
- Distribution
- Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1956-2018
- 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 fo
Terminated Class II Medical devices
- Recall started
- 27 October 2017
- Terminated
- 27 April 2020
- Reason
- The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.
- Distribution
- Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1195-2018
- Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.