FDA Device recall Z-1524-2022
ARIES SARS-CoV-2 Assay
- FDA Device
- Class II
- ongoing
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of ARIES SARS-CoV-2 Assay by Luminex, citing 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 mistak….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1524-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-07-14 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
ARIES SARS-CoV-2 Assay
Reason
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.
Identifiers
| code_info | Lot: AB4042A |
|---|
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-1524-2022%22
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