Z-1524-2022 Class II Ongoing
FDA device recall Z-1524-2022 was initiated by Luminex Corporation on July 14, 2022 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 257.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2022
- Initiation Date
- July 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 257
Product Description
ARIES SARS-CoV-2 Assay
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Code Information
Lot: AB4042A