Recall Z-0134-2023— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2022-09-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ARIES SARS-CoV-2 Assay, REF: 50-10047. 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..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-09-14
- Firm location
- Austin, TX, United States
Product description
ARIES SARS-CoV-2 Assay, REF: 50-10047
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.