Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NeuMoDx Cartridge-used for extraction Recalled by NeuMoDx Molecular Inc Due to Top label on some of the NeuMoDx cartridges...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NeuMoDx Molecular Inc directly.
Affected Products
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
Quantity: 20,016 cartridges
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NeuMoDx Molecular Inc
NeuMoDx Molecular Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report