ARIES SARS-CoV-2 Assay — Class II medical device recall Z-1524-2022
Ongoing recall by Luminex Corporation, reported 2022-08-24, distributed nationwide. SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results
| Recall number | Z-1524-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2022-07-14 |
| Classified | 2022-08-17 |
| Reported by FDA | 2022-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 257 |
| Reason classes | potency |
| Lot numbers | AB4042A |
Product
ARIES SARS-CoV-2 Assay
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1524-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.