CLASS III ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report
NeuMoDx Sars-CoV-2 Assay -Ivd intended recalled by NeuMoDx Molecular
NeuMoDx Molecular is recalling NeuMoDx Sars-CoV-2 Assay -Ivd intended for the qualitative detection of Sars-CoV-2 RNA, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class III.
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-2093-2023
- FDA event ID
- 92490
- Recalling firm
- NeuMoDx Molecular, Ann Arbor, MI
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 15 May 2023
- FDA classified
- 5 Jul 2023
- Reported
- 12 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 15 May 2023 | Recall initiated by company | |
| 5 Jul 2023 | Classified by FDA | +51 days |
| 12 Jul 2023 | 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
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.
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
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800
Where it was distributed
US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
Questions about this recall
Is NeuMoDx Sars-CoV-2 Assay -Ivd intended for the qualitative detection of Sars-CoV-2 RNA recalled?
Yes. NeuMoDx Molecular recalled NeuMoDx Sars-CoV-2 Assay -Ivd intended for the qualitative detection of Sars-CoV-2 RNA on 15 May 2023. The recall is Class III and its status is Ongoing. Recall number Z-2093-2023.
Why was it recalled?
Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.
Which lots are affected?
GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Where was it sold?
US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from NeuMoDx Molecular
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeuMoDx Cartridge-used for extraction, purification recalled | NeuMoDx Molecular | Other | Nationwide |
| Device | CLASS II | NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled | NeuMoDx Molecular | Lead & Heavy Metals | 10 states |
| Device | CLASS II | NeuMoDx Cartridge-For in vitro diagnostic use recalled | NeuMoDx Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled | NeuMoDx Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | NeuMoDx Cartridge, For In Vitro Diagnostic Use on recalled | NeuMoDx Molecular | Potency & Assay | MI |
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