Reported Jul 7, 2021 · Terminated
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
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, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
- Lot codes and dates
- GTIN10814278020274
- Lot Numbers106629 106630 106631 106632
- Amount recalled
- 620 cases (29,760 cartridges total)
Why it was recalled
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
This product could cause temporary or reversible health problems — stop using it.
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