Z-0134-2023Class II

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

Name: Z-0134-2023 ARIES SARS-CoV-2 Assay, REF: 50-10047
Creator: Luminex Corporation
Published: 2022-09-14
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2022-09-14 / Open, Classified / root cause: packaging

FDA source

Luminex Corporation began a recall of ARIES SARS-CoV-2 Assay, REF: 50-10047 on 2022-09-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0134-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-14
Posted: 2022-10-26
Recalling firm: Luminex Corporation
Product: ARIES SARS-CoV-2 Assay, REF: 50-10047
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: packaging
FDA 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 [email protected] 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 [email protected]. 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 in commerce: 5,141 (24 Cassettes)
Distribution: Distribution US nationwide, Indonesia, and Hong Kong.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0134-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-26

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)