medical Class II Updated 2023-08-09

NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-used for extraction, purification, amplifi

Recalled 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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528
View official government recall

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