FDA Medical Device Recalls (openFDA)
Luminex Corporation: ARIES SARS-CoV-2 Assay
- Recall number
- Z-1524-2022
- Recalling firm
- Luminex Corporation
- Product
- ARIES SARS-CoV-2 Assay
- Status
- Open, Classified
- Initiated
- 2022-07-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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
- Quantity
- 257
- Distribution
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- Lot, serial or model codes
- Lot: AB4042A
- 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