Reported Nov 2, 2022 · Ongoing
ARIES SARS-CoV-2 Assay, REF: 50-10047
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
- ARIES SARS-CoV-2 Assay
- REF50-10047
- Lot codes and dates
- Lot - Expiration
AB4723A - 05/25/2022AB5041A - 05/25/2022AB5060A - 06/01/2022AB5061A - 06/06/2022AB5081A - 06/07/2022AB5139A - 09/10/2022AB5141A - 09/16/2022AB5263A - 09/27/2022AB5282A - 10/05/2022AB6640A - 06/8/2023AB6720A - 06/13/2023
- Lot - Expiration
- Amount recalled
- 5,141 (24 Cassettes)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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