Lyra SARS-CoV-2 Assay (M120) (2021-04-27)

Starting date:

April 27, 2021

Posting date:

July 20, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76061

Last updated:
2021-07-20

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  Reason
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  Affected products

Affected Products 

Lyra SARS-CoV-2 Assay (M120)

Reason

Quidel has identified that rare situations patients infected with high viral load of SARS‐CoV‐2 may have samples that generate Ct values less‐than or equal to (≤) 5 when certain amplification and detection platforms are used. Based on the interpretation table in the package insert these specimens would be interpreted as negative.

Affected products