ARIES SARS-CoV-2 Assay, REF: 50-10047

FDA device recall Z-0134-2023 · posted 2022-10-26 · Open, Classified

Recall details

Recalling firm

Luminex Corporation

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.

Action taken

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.

Root cause

Packaging process control

Status

Open, Classified

Product code

QJR

Quantity affected

5,141 (24 Cassettes)

Distribution

Distribution US nationwide, Indonesia, and Hong Kong.

Date initiated

2022-09-14

Date posted

2022-10-26

Location

Austin, TX