FDA Device recall Z-2255-2023
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecul…
- FDA Device
- Class II
- ongoing
- Published 2023-08-09
On 2023-08-09 the FDA classified a Class II recall of NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecul… by Neumodx Molecular, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-24 |
| Published | 2023-08-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neumodx Molecular |
| Distribution | US |
Product
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
Reason
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
Identifiers
| code_info | GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2023%22
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