The Recall Desk
HighFDA (Devices)·Z-1106-2023·Announced 2023-02-15

Roche Influenza A/B and RSV Test Kit Recalled for False Negative Results

Roche Molecular Systems recalled 727 diagnostic test kits used to detect influenza and RSV due to reports of false negative influenza A results that could delay proper diagnosis and treatment.

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: This is an in-vitro diagnostic test that can produce false negative results for influenza A, a serious patient safety hazard. While this is an FDA Class II recall with no reported hospitalizations or illnesses, it represents a risk-of-harm product where patients could receive incorrect diagnostic results leading to delayed treatment.

Plain-English summary

Roche Molecular Systems, Inc. is recalling the cobas Influenza A/B & RSV UC (Utility Channel) qualitative nucleic acid test kits for use on cobas 6800/8800 Systems. This is an in-vitro diagnostic test used to detect influenza A, influenza B, and respiratory syncytial virus (RSV).

The recall was initiated due to customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. These false negative results may lead to patients not being properly diagnosed with influenza A, resulting in additional testing, psychological distress, and delays to targeted therapy for influenza.

The recall affects 727 kits with UDI-DI 00875197006773 and all in-date lots. Distribution was domestic nationwide and worldwide. Clinical laboratories and diagnostic testing facilities using these test kits should discontinue use of affected lots and consult Roche for replacement or alternative testing options.

The recalled product

Product
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Manufacturer
Roche Molecular Systems, Inc.
Category
Medical Device — In-Vitro Diagnostic
Hazard
  • diagnostic-error
  • delayed-diagnosis

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)

  • UDI-DI 00875197006773 All in-date lots

Distribution

Distributed nationwide across the United States.

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