NeuMoDx Molecular Inc: 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: 100

Hazard

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE Quantity: 20,016 cartridges Lot/code info: GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528

UPC codes

10814278020274

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.