NeuMoDx COVID-19 test cartridges recalled for false positive risk
NeuMoDx Molecular is recalling diagnostic cartridges used in COVID-19 and flu/RSV tests because of potential for false positive SARS-CoV-2 results, which could lead to incorrect patient management.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with potential for false positive diagnostic results. No illnesses or injuries have been reported, and the hazard is potential rather than confirmed. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
NeuMoDx Molecular Inc is recalling NeuMoDx Cartridges used with NeuMoDx Molecular Systems for in vitro diagnostic testing. The recalled cartridges are used with the NeuMoDx SARS-CoV-2 Test Strip (REF 300800) and the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900).
These cartridges have the potential to produce false positive results specifically for SARS-CoV-2 detection. False positive test results could lead to incorrect patient management.
The recall affects 773 cases (72 cases in the United States and 701 cases worldwide). In the U.S., affected cartridges were distributed to Ohio, Missouri, Virginia, Michigan, Florida, Maryland, Iowa, and New York. Internationally, cartridges were distributed to Italy, Germany, Switzerland, Sweden, Netherlands, Finland, Spain, United Kingdom, Belgium, Austria, Hong Kong, France, Denmark, and Slovenia. Affected lot numbers are 115424, 115425, 115426, 115427, 115429, and 115431.
The recalled product
- 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-Co
- Manufacturer
- NeuMoDx Molecular Inc
- Hazard
- false-positive
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot Numbers: 115424
- 115425
- 115426
- 115427
- 115429
- 115431. GTIN: 10814278020274
Distribution
Distributed nationwide across the United States.
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