NeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
NeuMoDx Molecular Inc is recalling 20,016 cartridges from three lots due to incorrect label placement during manufacturing. Misplaced labels may interfere with optical performance, increasing risk for false positive test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall presenting risk-of-harm through potential false positive test results due to optical interference. No illnesses or injuries have been reported, meeting the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
NeuMoDx Molecular Inc is recalling 20,016 NeuMoDx Cartridges (Ref: 100100) used with the NeuMoDx 288 and NeuMoDx 96 Molecular Systems. The cartridges are used for extraction, purification, amplification, and detection of nucleic acids. The recall involves cartridges from lots 117514, 117524, and 117528 (GTIN: 10814278020274).
The recall was initiated because the top label on cartridges in these lots may have been incorrectly applied during manufacturing, resulting in encroachment into the PCR region. This misplacement may interfere with the module's optical performance, thereby increasing the risk for false positive test results.
The affected cartridges have been distributed nationwide in Kansas, Florida, Texas, Ohio, New York, Michigan, and Pennsylvania in the United States, and internationally to Austria, Belgium, Switzerland, Germany, Spain, Finland, France, the United Kingdom, Italy, Latvia, Poland, Romania, and Sweden.
The recalled product
- 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
- Manufacturer
- NeuMoDx Molecular Inc
- Affected units
- 20,016
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 (3)
- GTIN: 10814278020274 Lot Numbers: 117514
- 117524
- and 117528
Distribution
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