ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
FDA Recall Z-0553-2022 · Posted None
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Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodeOOI
Date Initiated2021-11-17
Date Terminated2024-07-08
Product Quantity329
Reason for Recall
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.
Firm 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 [email protected].
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 [email protected] 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),
[email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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