FDA Device recall Z-0134-2023
ARIES SARS-CoV-2 Assay, REF: 50-10047
- FDA Device
- Class II
- ongoing
- Published 2022-11-02
On 2022-11-02 the FDA classified a Class II recall of ARIES SARS-CoV-2 Assay, REF: 50-10047 by Luminex, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0134-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-14 |
| Published | 2022-11-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
ARIES SARS-CoV-2 Assay, REF: 50-10047
Reason
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.
Identifiers
| code_info | Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 0…Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2023%22
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