The Recall Desk
HighFDA (Devices)·Z-2498-2021·Announced 2021-09-29

cobas SARS-CoV-2 and Influenza A/B Test Recalled Due to False Positive Results

Roche Molecular Systems is recalling cobas SARS-CoV-2 & Influenza A/B test kits following reports of increased false positive SARS-CoV-2 results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II recall with reported false positive diagnostic results. No illnesses or injuries have been documented. Diagnostic inaccuracy represents a risk-of-harm product where patient impact has not yet been reported.

Plain-English summary

Roche Molecular Systems, Inc. is recalling the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System (Catalog Number 09211101190). The affected lot is 10119Z.

Customers have reported an increased number of false positive SARS-CoV-2 results from these test kits. A total of 211 kits were distributed in the United States across 15 states, and 3073 kits were distributed internationally to Canada, the United Kingdom, and 12 European countries.

Healthcare providers and laboratory personnel using these kits from the affected lot should contact Roche Molecular Systems, Inc. for guidance on this issue.

The recalled product

Product
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Manufacturer
Roche Molecular Systems, Inc.
Category
Medical Device — Diagnostic Test Kit
Hazard
  • false-positive-results
  • diagnostic-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 10119Z

Distribution

Distributed nationwide across the United States.

Related recalls

Same category