NeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results
NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II medical device recall involves a theoretical risk of false positive diagnostic results that could lead to patient harm. No illnesses or injuries have been reported, fitting the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
NeuMoDx Molecular Inc. is recalling 620 cases (29,760 cartridges) of NeuMoDx Cartridges for use on NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100, distributed worldwide.
Cartridges with lot numbers 106629, 106630, 106631, and 106632 have a potential to produce false positive results when used with certain assays. A false positive result incorrectly indicates the presence of a disease, condition, or organism.
This recall affects diagnostic laboratories, clinical providers, and healthcare facilities using the NeuMoDx 288 or NeuMoDx 96 systems. Any testing performed using these cartridge lots should be reviewed for accuracy.
Healthcare providers should contact NeuMoDx Molecular Inc. or review FDA guidance for instructions on handling recalled cartridges and addressing tests already completed with these lots.
The recalled product
- Product
- NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
- Manufacturer
- NeuMoDx Molecular Inc
- Hazard
- false-positive-results
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 10814278020274
- Lot Numbers: 106629 106630 106631 106632
Distribution
Distribution scope not specified by the agency.
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