Luminex recalls ARIES SARS-CoV-2 Assay (Lot AB4042A) due to potential false negatives from missed ORF1ab gene detection. Consumers should verify test results with a different test.
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.
“Luminex ARIES SARS-CoV- 2 Assay Recall: False Negative Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60366-luminex-aries-sars-cov-2-assay-recall-false-negative-risk. Based on FDA recall #Z-1524-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1524-2022%22&limit=1).
The FDA announced on July 14, 2022, that Luminex Corporation is recalling the ARIES SARS-CoV-2 Assay because it may fail to detect the ORF1ab gene, potentially causing false negative results. The agency issued recall number Z-1524-2022 for the voluntary Class II action.
How to tell if you have it
Brand: Luminex
Product: ARIES SARS-CoV-2 Assay
Lot code: AB4042A
The hazard
The assay detects SARS-CoV-2 ORF1ab and N genes, but a positive result occurs if either gene is detected. If both genes are mistakenly not detected, a false negative result would be generated.
Context
GovInfoNow's records show Luminex Corporation has had 22 other recalls since May 8, 2018. Recent examples include the April 16, 2025 VERIGENE Gram Negative Blood Culture Test Recall and the June 20, 2024 Verigene Gram Positive Blood Culture Test Recall. Other recent recalls of similar products include the BioFire Spotfire Respiratory Panel Recall (April 1, 2026) and the Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026).
How to tell if you have this one
Check the lot number on the test kit. The affected product is the ARIES SARS-CoV-2 Assay with lot number AB4042A.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Lot Number
Look for the lot number AB4042A on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Kentucky, Maine, Mississippi, Nebraska, Tennessee, Texas.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1524-2022 (July 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1524-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.