ARIES SARS-CoV-2 Assay may produce false negative diagnostic results
Luminex Corporation recalled 257 units of the ARIES SARS-CoV-2 Assay (lot AB4042A) due to potential false negative results. The assay may fail to detect the ORF1ab gene, risking missed COVID-19 infections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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: Risk-of-harm diagnostic medical device with potential to generate false negative results. This is an FDA Class II recall with no reported illnesses or injuries in the source material, fitting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
The FDA is reviewing a recall of the ARIES SARS-CoV-2 Assay, a diagnostic test manufactured by Luminex Corporation designed to detect SARS-CoV-2 infection. Approximately 257 units with lot number AB4042A were distributed across multiple U.S. states including Nebraska, Texas, Mississippi, Tennessee, Kentucky, Maine, and California.
The assay is designed to detect two viral genes indicating SARS-CoV-2 infection: ORF1ab and N genes. The defect is that the assay may fail to reliably detect the ORF1ab gene. Because a positive test result occurs when either gene is detected, if both genes are not detected due to the defect, the assay will incorrectly produce a false negative result, potentially missing COVID-19 infections.
Laboratories should contact Luminex Corporation for guidance regarding the use or replacement of affected units in lot AB4042A.
The recalled product
- Product
- ARIES SARS-CoV-2 Assay
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
- Affected units
- 257
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)
- Lot: AB4042A
Distribution
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