FDA Medical Device Recalls (openFDA)
Luminex Corporation: ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
- Recall number
- Z-0553-2022
- Recalling firm
- Luminex Corporation
- Product
- ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
- Status
- Terminated
- Initiated
- 2021-11-17
- Posted
- not on file
- Terminated
- 2024-07-08
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 11/17/2021, the firm notified affected customers via letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated, if you observe any leaks, please contact Luminex Global Support Services at support@luminexcorp.com. Please inform all those who need to be aware within your organization of this potential product performance issue. Please contact Luminex Global Support Services at support@luminexcorp.com at your earliest convenience if you have a Kit with an affected lot to arrange for its replacement, and to confirm the disposal of any remaining Kits in your inventory. We ask that you complete and return the attached acknowledgement letter so that we can confirm the destruction of recalled lots. Luminex Global Support Services, 1-877-785-2323 (U.S. and Canada}, +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com
- Quantity
- 329
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia.
- Lot, serial or model codes
- Lot Numbers AB3600A and AB3560A
- 510(k) numbers
- ["K161495"]
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 3002524000
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28