ARIES SARS-CoV-2 Assay Recalled Due to Syringe Defect
Luminex is recalling certain lots of the ARIES SARS-CoV-2 Assay because a defect in the wash 1 syringe could cause incomplete sample extraction and produce false negative test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall. The defect could result in false negative assay results, which poses a risk of harm to patients. However, no illnesses, injuries, or adverse events have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a High (3) score.
Plain-English summary
Luminex Corporation is recalling certain lots of the ARIES SARS-CoV-2 Assay (REF: 50-10047) due to a defect in the wash 1 syringe that can cause incomplete sample extraction. The defect may result in invalid or false negative assay results.
A total of 5,141 units containing 24 cassettes are affected by this recall. The affected units were distributed in the United States nationwide, as well as in Indonesia and Hong Kong. Specific lot numbers and expiration dates are available from the FDA.
The recalled product
- Product
- ARIES SARS-CoV-2 Assay, REF: 50-10047
- Manufacturer
- Luminex Corporation
- Category
- Medical Device — Diagnostic Test
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
Distributed nationwide across the United States.
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