ARIES HSV 1&2 Assay, Part Number/REF 50-10017
FDA Recall Z-0498-2022 · Posted None
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Recalling FirmLuminex Corporation
Recall StatusTerminated
Product CodeOOI
Date Initiated2021-04-16
Date Terminated2024-09-20
Product Quantity296 kits
Reason for Recall
Impacted lot may leak inside the ARIES instrument.
Firm Action
On 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April 26th, 2021.
We appreciate your assistance with this matter. Please call Luminex's Global Support Services if you have any questions or concerns.
Luminex Global Support Services
1-877-785-2323 (U .S. and Canada)
+1-512-381-4397 (Outside U.S. and Canada)
[email protected]
CAN-0282, Rev A
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan.
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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