Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems Recalled by NeuMoDx Molecular Inc Due to Potential for false positive results for SARS-CoV-2 in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NeuMoDx Molecular Inc directly.
Affected Products
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx 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 Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100
Quantity: 773 (72 US and 701 ROW) cases (48 cartridges/case)
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NeuMoDx Molecular Inc
NeuMoDx Molecular Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report