ARIES SARS-CoV-2 Assay — Class II medical device recall Z-0134-2023
Ongoing recall by Luminex Corporation, reported 2022-11-02, distributed nationwide. A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby produ
| Recall number | Z-0134-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2022-09-14 |
| Classified | 2022-10-26 |
| Reported by FDA | 2022-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK, ID |
| Reason classes | potency |
| Lot numbers | AB4723A, AB5041A, AB5060A, AB5061A, AB5081A, AB5139A, AB5141A, AB5263A, AB5282A, AB6640A, AB6720A |
| Model numbers | 50-10047 |
Product
ARIES SARS-CoV-2 Assay, REF: 50-10047
Reason for recall
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.
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-0134-2023. 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.