RecallRadar

FDA Device recall Z-0498-2022

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

On 2022-01-26 the FDA classified a Class II recall of ARIES HSV 1&2 Assay, Part Number/REF 50-10017 by Luminex, citing impacted lot may leak inside the ARIES instrument.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0498-2022
ClassificationClass II
Statusterminated
Initiated2021-04-16
Published2022-01-26
Last updated2026-09-13 11:56 UTC
CompanyLuminex
DistributionUS

Product

ARIES HSV 1&2 Assay, Part Number/REF 50-10017

Reason

Impacted lot may leak inside the ARIES instrument.

Identifiers

code_infoLot number AB1703A

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-0498-2022%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.