ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Recall
- Recall Number
- Z-0553-2022
- Event Number
- 89244
- Firm
- Luminex Corporation
- FEI Number
- 3002524000
- Product Code
- OOI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 17, 2021
- Terminated
- July 8, 2024
- Address
- 12212 Technology Blvd, Austin, TX, 78727-6101
Description
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
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.
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]
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.
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