Aries Sars-cov-2 Assay recall
ARIES SARS-CoV-2 Assay, REF: 50-10047
Why was Aries Sars-cov-2 Assay 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ARIES SARS-CoV-2 Assay, REF: 50-10047
- Recalling firm
- Luminex Corporation
- Quantity
- 5,141 (24 Cassettes)
- Distribution
- Distribution US nationwide, Indonesia, and Hong Kong.
- Recall date
- November 2, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)