FDA Recalls Diagnostic Test Strips for False Positive Results
NeuMoDx COVID-19 test strips (Lot 116305 S/L-02) are recalled due to product contamination that increases risk of false positive results. The recall affects 102 boxes distributed in FL, MD, MI, and NY.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall for product contamination creating risk of false positive SARS-CoV-2 test results. No illnesses or injuries have been reported, but false positives represent a documented risk of harm through unnecessary medical intervention.
Plain-English summary
NeuMoDx Molecular Inc is recalling 102 boxes of NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strips (Ref # 300900, Lot 116305 S/L-02) due to product contamination identified in the affected lot.
The contaminated test strips were distributed in Florida, Maryland, Michigan, and New York. Use of the affected product may result in false positive results for SARS-CoV-2, which could lead consumers to unnecessary medical treatment or quarantine.
Customers with this product should immediately stop using it and contact their healthcare provider. Healthcare facilities should identify any test results from Lot 116305 S/L-02 and take appropriate action regarding potentially false positive results. The affected lot can be identified by lot number 116305 S/L-02 printed on the box, pouch, and individual test strips.
The recalled product
- Product
- NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
- Manufacturer
- NeuMoDx Molecular Inc
- Affected units
- 102
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 (2)
- Lot: 116305 S/L-02 (Sublot 02)
- UDI: 10814278020830
Distribution
Related recalls
Same manufacturer · NeuMoDx Molecular Inc
See all →- HighNeuMoDx Diagnostic Cartridges Recalled for Label Misplacement Risk
FDA (Devices) · 2023-08-09
- ModerateCOVID-19 Test Strips Recalled for Lot Number Label Discrepancy
FDA (Devices) · 2023-07-12
- HighMedical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens
FDA (Devices) · 2022-06-15
- HighNeuMoDx COVID-19 test cartridges recalled for false positive risk
FDA (Devices) · 2022-05-04
- HighNeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results
FDA (Devices) · 2021-07-07
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighMedical Device Test Strip Recall: Potential False Negatives for Respiratory Pathogens
FDA (Devices) · 2022-06-15
- HighNeuMoDx COVID-19 test cartridges recalled for false positive risk
FDA (Devices) · 2022-05-04
- ModerateCOVID-19 Test Strips Recalled for Lot Number Label Discrepancy
FDA (Devices) · 2023-07-12
- HighLumiraDx SARS-CoV-2 Antigen Test Strips Recalled for False Positives
FDA (Devices) · 2021-02-24
- HighNeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results
FDA (Devices) · 2021-07-07
- HighDASH COVID and flu tests may give a false negative result
FDA (Devices) · 2025-08-13