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Luminex Corporation Recall 90937

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

Luminex Corporation Recall 90937 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0134-2023
Event ID90937
Event DescriptionARIES SARS-CoV-2 Assay, REF: 50-10047
Product TypeDevices
DistributionDistribution US nationwide, Indonesia, and Hong Kong.
Quantity5,141 (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, AB6640A - 06/8/2023, AB6720A - 06/13/2023
Center Classification Date20221026
Recall Initiation Date20220914
Recalling FirmLuminex Corporation
Initial Notification Letter
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