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Recall Observatory FDA recall evidence

Device product

ARIES SARS-CoV-2 Assay

Z-1524-2022

July 14, 2022

Class II

Product summary

Firm
Luminex Corporation
Event
Event 90698
Status
Ongoing
Classification
Class II
Quantity
257
Official record key
device-enforcement:Z-1524-2022

Official wording

Reason: SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Code information: Lot: AB4042A

Distribution pattern: U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.