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Luminex Corporation Recall 89244

Description: ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

Luminex Corporation Recall 89244 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0553-2022
Event ID89244
Event DescriptionARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Product TypeDevices
DistributionWorldwide 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.
Recall ReasonImpacted 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.
Device Classification20220209
Device Code InfoLot Numbers AB3600A and AB3560A
Center Classification Date20220202
Recall Initiation Date20211117
Recalling FirmLuminex Corporation
Initial Notification E-Mail
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