[Recalled] 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 — Top label on some of the NeuMoDx cartridges w
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | NeuMoDx Molecular Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2255-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 May 2023 |
| EAN / barcode | 10814278020274 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.