CLASS II ONGOING Device recall · Reported 6 Apr 2022 · FDA Enforcement Report
cobas LiatSystem, respiratory virus panel nucleic acid recalled
Roche Molecular Systems is recalling cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number, distributed nationwide in the US. The recall was initiated on 16 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0828-2022
- FDA event ID
- 89643
- Recalling firm
- Roche Molecular Systems, Branchburg, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Nov 2021
- FDA classified
- 28 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- CPAP & Ventilators
Timeline
| 16 Nov 2021 | Recall initiated by company | |
| 28 Mar 2022 | Classified by FDA | +132 days |
| 6 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Where it was distributed
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.
Nationwide ColoradoIllinoisIndianaKentuckyMichiganNorth CarolinaTexas
Questions about this recall
Is cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number recalled?
Yes. Roche Molecular Systems recalled cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number on 16 Nov 2021. The recall is Class II and its status is Ongoing. Recall number Z-0828-2022.
Why was it recalled?
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.
Which lots are affected?
UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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