CLASS II ONGOING Device recall · Reported 24 Aug 2022 · FDA Enforcement Report

Aries Sars-CoV-2 Assay recalled by Luminex

Luminex is recalling Aries Sars-CoV-2 Assay, distributed nationwide in the US. The recall was initiated on 14 Jul 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: AB4042A

Quantity recalled257

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1524-2022
FDA event ID: 90698
Recalling firm: Luminex, Austin, TX
Classification: Class II
Status: Ongoing
Recall initiated: 14 Jul 2022
FDA classified: 17 Aug 2022
Reported: 24 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

14 Jul 2022	Recall initiated by company
17 Aug 2022	Classified by FDA	+34 days
24 Aug 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

ARIES SARS-CoV-2 Assay

Where it was distributed

U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

Nationwide California Kentucky Maine Mississippi Nebraska Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot: AB4042A

Where was it sold?

U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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