NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids...
FDA Recall #Z-2255-2023 — Class II — May 24, 2023
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
Recalling Firm
NeuMoDx Molecular Inc — Ann Arbor, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
20,016 cartridges
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
Code Information
GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.