ARIES SARS-CoV-2 Assay
This recall is currently active, issued July 14, 2022. It was issued by Luminex Corporation.
- Company
- Luminex Corporation
- Recall Initiated
- July 14, 2022
- Recall Number
- Z-1524-2022
- Quantity
- 257
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
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
U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Lot / Code Info
Lot: AB4042A
Root Cause
Nonconforming Material/Component
Action Taken
On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded. Customers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com