Recall Z-2255-2023— NeuMoDx Molecular Inc
Class II · Ongoing
Class II FDA medical device recall by NeuMoDx Molecular Inc, initiated 2023-05-24. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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.
- Recalling firm
- NeuMoDx Molecular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-05-24
- Firm location
- Ann Arbor, MI, United States
Product description
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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.