Reported Aug 9, 2023 · Ongoing
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288…
NeuMoDx Molecular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuMoDx Molecular Inc · 1250 Eisenhower Pl · Ann Arbor, MI · 48108-3281
Is this the product you have?
- NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular
- Systems (NeuMoDx System(s) Ref100100
- Lot codes and dates
- GTIN10814278020274
- Lot Numbers
117514117524and 117528
- Amount recalled
- 20,016 cartridges
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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