Luminex Corporation ARIES SARS-CoV-2 Assay, REF: 50-10047 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On 09/14/22, recall notices were emailed to customers who were asked to do the following: 1. Cease all use, and isolate or quarantine affected devices pending disposal. 2. If affected devices are identified, contact the recalling firm at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results obtained using the affected SARS-CoV-2 Assay. If you suspect that you have encountered a false negative result with a patient sample, please contact the recalling firm at support@luminexcorp.com. 4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. 5. If affected devices were further distributed, notify your customers of this recall. 6. Please complete and return the Acknowledgement & Receipt Form. 7. For those with complaints, questions, or concerns, please contact Global Technical Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381 -4397 (Outside U.S. and Canada). On 12/05/22, additional recall notices were sent to customers notifying them that two additional lots were impacted.