Z-1524-2022Class II

ARIES SARS-CoV-2 Assay

Name: Z-1524-2022 ARIES SARS-CoV-2 Assay
Creator: Luminex Corporation
Published: 2022-07-14
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2022-07-14 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of ARIES SARS-CoV-2 Assay on 2022-07-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1524-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-14
Posted: 2022-08-17
Recalling firm: Luminex Corporation
Product: ARIES SARS-CoV-2 Assay
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Reason for recall: 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 tag: manufacturing process
FDA 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), [email protected]
Quantity in commerce: 257
Distribution: U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
Product codes and lots: Lot: AB4042A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-24	2022-08-17

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)