Agency classClass IOur severity:Severe FDA (Devices)·Z-1928-2021·Announced 2021-07-07

Quidel Lyra SARS-CoV-2 Assay Kits Recalled for Potential False Negatives

Quidel Corporation is recalling approximately 29,787 kits of the Lyra SARS-CoV-2 Assay due to a theoretical risk that samples with very high viral loads could produce false negative results. No false negatives have been formally reported.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would…"

Plain-English summary

Quidel Corporation has recalled the Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent due to a potential risk of false negative results. The recall affects approximately 29,787 kits distributed nationwide across 18 US states (Alabama, California, Connecticut, Washington DC, Florida, Idaho, Indiana, Massachusetts, Michigan, Missouri, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas, and Washington) and internationally to Canada, Saudi Arabia, and the United Kingdom.

The FDA classified this as a Class I recall. In rare situations, patient samples with very high SARS-CoV-2 viral loads may generate cycle threshold (Ct) values of 5 or less. On certain thermocycler platforms, if target amplification occurs before the Ct value reaches 5, these samples could be falsely reported as negative, potentially missing an active COVID-19 infection.

Laboratories and healthcare facilities using the affected lot numbers should immediately discontinue use of the recalled kits and contact Quidel Corporation for guidance or replacement products. The manufacturer reports that no false negative results have been formally reported by users of the Lyra SARS-CoV-2 Assay, though the theoretical risk prompted the recall.

The recalled product

Product: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Manufacturer: Quidel Corporation
Category: Medical Device — Diagnostic Test Reagent
Hazard: false-negative-result
diagnostic-error

Distribution

Distributed nationwide across the United States.

The notice also names 17 states specifically:

Same manufacturer · Quidel Corporation

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