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Open, Classified

ARIES SARS-CoV-2 Assay

FDA Recall Z-1524-2022 · Posted None

Recalling FirmLuminex Corporation
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2022-07-14
Product Quantity257

Reason for Recall

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.

Firm Action

On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded. Customers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), [email protected]

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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