CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
NeuMoDx Cartridge-used for extraction, purification recalled
NeuMoDx Molecular is recalling NeuMoDx Cartridge-used for extraction, purification, amplification and detection of, distributed nationwide in the US. The recall was initiated on 24 May 2023 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-2255-2023
- FDA event ID
- 92615
- Recalling firm
- NeuMoDx Molecular, Ann Arbor, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 May 2023
- FDA classified
- 28 Jul 2023
- Reported
- 9 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 May 2023 | Recall initiated by company | |
| 28 Jul 2023 | Classified by FDA | +65 days |
| 9 Aug 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Product as listed by the FDA
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Where it was distributed
US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE
Nationwide DelawareFloridaKansasMichiganNew YorkOhioPennsylvaniaTexas
Questions about this recall
Is NeuMoDx Cartridge-used for extraction, purification, amplification and detection of recalled?
Yes. NeuMoDx Molecular recalled NeuMoDx Cartridge-used for extraction, purification, amplification and detection of on 24 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2255-2023.
Why was it recalled?
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Which lots are affected?
GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528
Where was it sold?
US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE
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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