Luminex Corporation ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Brand
Luminex Corporation
Lot Codes / Batch Numbers
Lot Numbers AB3600A and AB3560A
Products Sold
Lot Numbers AB3600A and AB3560A
Luminex Corporation is recalling ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 due to Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect result. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026