Reported May 4, 2022 · Ongoing
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays:…
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 with NeuMoOx Molecular Systems
- with either of the following assaysNeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs)
- for SARS-CoV-2 RNA detection NoteResults for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref
- Number100100
- Lot codes and dates
- Lot Numbers
115424115425115426115427115429115431
- GTIN10814278020274
- Lot Numbers
- Amount recalled
- 773 (72 US and 701 ROW) cases (48 cartridges/case)
Where it was sold
Why it was recalled
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
This product could cause temporary or reversible health problems — stop using it.
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