FDA Device recall Z-0553-2022
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
- FDA Device
- Class II
- terminated
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 by Luminex, citing impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0553-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-17 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Reason
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
Identifiers
| code_info | Lot Numbers AB3600A and AB3560A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0553-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.