Product Safety Recalls

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Luminex Corporation Recall 90937

Description: ARIES SARS-CoV-2 Assay, REF: 50-10047

Luminex Corporation Recall 90937 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0134-2023
Event ID90937
Event DescriptionARIES SARS-CoV-2 Assay, REF: 50-10047
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, WV, WY, UT and the countries of Indonesia, Hong Kong.
Quantity3,893 (24 Cassettes)
Recall ReasonA part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
Device Classification20221102
Device Code InfoLot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022
Center Classification Date20221026
Recall Initiation Date20220914
Recalling FirmLuminex Corporation
Initial Notification Letter
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