Recall Z-0553-2022
Luminex Corporation · initiated November 17, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Codes / lots: Lot Numbers AB3600A and AB3560A
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0553-2022
- Initiated
- November 17, 2021
- Terminated
- July 8, 2024
- Product code
- OOI – Real Time Nucleic Acid Amplification System
- 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.
- Recalling firm
- Luminex Corporation, Austin, TX