Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 29, 2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Customers have reported an increased number of false positive SARS-CoV-2 results.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Molecular Systems, Inc. recalled cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09… - a moderate-severity action.
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09… was recalled by Roche Molecular Systems, Inc. in September 29, 2021. Reason: Customers have reported an increased number of false positive SARS-CoV-2 results.. Check the official notice for the remedy. Verify recall #Z-2498-2021 with the FDA Devices before acting.
The recall
Roche Molecular Systems, Inc. issued this moderate-severity FDA Devices recall-Customers have reported an increased number of false positive SARS-CoV-2 results..
- Moderate
- severity level
- Class II
- classification
- September 29, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2498-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2498-2021) was formally reported on September 29, 2021, with the manufacturer initiating the action on August 4, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Molecular Systems, Inc. is listed as the recalling firm, operating out of Branchburg, NJ. Federal records list the affected scope as 211 kits (US); 3073 kits (OUS).
The documented reason for this recall is: Customers have reported an increased number of false positive SARS-CoV-2 results. Distribution data in the federal record shows the product reached: 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, Germ…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
211 kits (US); 3073 kits (OUS)
Related Recalls
6
3 from same agency
Product description
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Reason for recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2498-2021 |
| Date reported | September 29, 2021 |
| Date initiated | August 4, 2021 |
| Recalling firm | Roche Molecular Systems, Inc. |
| Firm location | Branchburg, NJ |
| Affected scope | 211 kits (US); 3073 kits (OUS) |
| 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, No… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2498-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190. Recalled by Roche Molecular Systems, Inc.. Units affected: 211 kits (US); 3073 kits (OUS).
Why was this product recalled? ▼
Customers have reported an increased number of false positive SARS-CoV-2 results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2498-2021.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2498-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 29, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.