Aries Sars-cov-2 Assay recall
ARIES SARS-CoV-2 Assay
Why was Aries Sars-cov-2 Assay recalled?
SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.
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: AB4042A
- Product
- ARIES SARS-CoV-2 Assay
- Recalling firm
- Luminex Corporation
- Quantity
- 257
- Distribution
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- Recall date
- August 24, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)