A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
Luminex is recalling specific lots of their ARIES SARS-CoV-2 Assay kits because a defect in the wash 1 syringe might cause false negative results. This means the test could incorrectly show a negative result when the person is actually infected. Read more at govinfonow.com/recall/60061-luminex-aries-sars-cov-2-assay-recall-false-negative-risk.
“Luminex ARIES SARS-CoV-2 Assay Recall: False Negative Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60061-luminex-aries-sars-cov-2-assay-recall-false-negative-risk. Based on FDA recall #Z-0134-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2023%22&limit=1).
The FDA announced on Sept. 14, 2022, that Luminex Corporation is recalling the ARIES SARS-CoV-2 Assay due to a part defect that may produce invalid or false negative results. The agency issued recall number Z-0134-2023 for the voluntary Class II action.
Distribution: US nationwide, Indonesia, and Hong Kong
The hazard
According to the FDA, a defect in the wash 1 syringe of the SARS-CoV-2 assay could lead to incomplete extraction. This may produce an invalid or false negative assay result.
Context
GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include the Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025), the Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024), and the Luminex VERIGENE BC-GP Utility Tray Recall (Nov. 7, 2023). Other recent recalls of similar products include the Hologic Aptima HPV Assay Kit Recall (Feb. 18, 2026), the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and the BioFire Respiratory Panel 2.1 Recall (Oct. 22, 2025).
How to tell if you have this one
Check the lot number on the kit packaging, which is listed as AB4723A through AB6720A with expiration dates from May 2022 to June 2023.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for the lot number on the kit packaging, which is listed as AB4723A through AB6720A with expiration dates from May 2022 to June 2023.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US nationwide, Indonesia, and Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 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-0134-2023 (September 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0134-2023 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.