Z-0553-2022 Class II Terminated
FDA device recall Z-0553-2022 was initiated by Luminex Corporation on November 17, 2021 and is designated Class II. 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 Invali… The recall status is terminated (terminated July 8, 2024). Affected quantity: 329.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- November 17, 2021
- Termination Date
- July 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 329
Product Description
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
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.
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.
Code Information
Lot Numbers AB3600A and AB3560A