Recall archive / FDA device enforcement
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: Neu... — FDA record Z-1000-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- 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
- Classification
- Class II
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 773 (72 US and 701 ROW) cases (48 cartridges/case)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1000-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of OH, MO, VA, MI, MI, FL, MD, IA, NY, MO and the countries of Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, Slovenia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Feb 18, 2022
- Center classification date
- Apr 22, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.