The Recall Desk
HighFDA (Devices)·Z-2477-2021·Announced 2021-09-22

Lyra Direct SARS-CoV-2 Assay Instructions Revised for False Negative Risk

The Lyra Direct SARS-CoV-2 assay can produce false negatives on certain PCR machines when specimens have high viral loads. Revised instructions address this diagnostic failure risk affecting approximately 81,910 kits distributed worldwide.

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: FDA Class II device with documented false negative risk affecting COVID-19 diagnostic accuracy. Source text does not report illnesses or injuries, qualifying as a risk-of-harm product where injury has not yet been reported per rubric score 3.

Plain-English summary

The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR diagnostic test manufactured by Quidel Corporation for detecting COVID-19 in patients with suspected infection. The FDA has identified a potential failure mode affecting the test's performance.

Under specific conditions, nasal, nasopharyngeal, or oropharyngeal specimens from patients with high SARS-CoV-2 viral loads may be falsely interpreted as negative when using certain laboratory equipment. The failure occurs when target amplification happens before a cycle-threshold value of 5. Affected equipment includes the Thermo Fisher QuantStudio 7 Pro, Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500, Bio-Rad CFX96 Touch, Roche LightCycler LC 480 II/cobas z 480, and Qiagen Rotor-Gene MDx. Approximately 81,910 kits from all lot numbers have been distributed worldwide to the United States, Puerto Rico, Canada, Panama, Virgin Islands, Germany, and Honduras.

Quidel Corporation has issued revised Instructions for Use to address this issue. Laboratories using this assay on the affected equipment models should consult the updated guidance.

The recalled product

Product
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab speci
Manufacturer
Quidel Corporation
Category
Medical Device — Diagnostic Test / COVID-19
Hazard
  • false-negative

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)

  • All lots

Distribution

Distributed nationwide across the United States.

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