Recall Z-1524-2022
Luminex Corporation · initiated July 14, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ARIES SARS-CoV-2 Assay
Codes / lots: Lot: AB4042A
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.
FDA-determined 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
Details
- Recall number
- Z-1524-2022
- Initiated
- July 14, 2022
- Product code
- QJR – Reagents, 2019-Novel Coronavirus Nucleic Acid
- Quantity
- 257
- Distribution
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- Recalling firm
- Luminex Corporation, Austin, TX