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Recall Observatory FDA recall evidence

Device product

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

Z-0134-2023

September 14, 2022

Class II

Product summary

Firm
Luminex Corporation
Event
Event 90937
Status
Ongoing
Classification
Class II
Quantity
5,141 (24 Cassettes)
Official record key
device-enforcement:Z-0134-2023

Official wording

Reason: A 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.

Code information: Lot - 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

Distribution pattern: Distribution US nationwide, Indonesia, and Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A 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.