CLASS II ONGOING Device recall · Reported 2 Nov 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 Sep 2022 and the FDA has classified it as Class II.
Check your package
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-0134-2023
- FDA event ID
- 90937
- Recalling firm
- Luminex, Austin, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Sep 2022
- FDA classified
- 26 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Sep 2022 | Recall initiated by company | |
| 26 Oct 2022 | Classified by FDA | +42 days |
| 2 Nov 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
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ARIES SARS-CoV-2 Assay, REF: 50-10047
Where it was distributed
Distribution US nationwide, Indonesia, and Hong Kong.
Questions about this recall
Is Aries Sars-CoV-2 Assay recalled?
Yes. Luminex recalled Aries Sars-CoV-2 Assay on 14 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0134-2023.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Distribution US nationwide, Indonesia, and Hong Kong.
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 21 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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