FDA Medical Device Recalls (openFDA)
Luminex Corporation: ARIES SARS-CoV-2 Assay, REF: 50-10047
- Recall number
- Z-0134-2023
- Recalling firm
- Luminex Corporation
- Product
- ARIES SARS-CoV-2 Assay, REF: 50-10047
- Status
- Open, Classified
- Initiated
- 2022-09-14
- Posted
- 2022-10-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 5,141 (24 Cassettes)
- Distribution
- Distribution US nationwide, Indonesia, and Hong Kong.
- Lot, serial or model codes
- Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3002524000
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28