CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled
NeuMoDx Molecular is recalling NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip, distributed nationwide in the US. The recall was initiated on 21 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0738-2022
- FDA event ID
- 89675
- Recalling firm
- NeuMoDx Molecular, Ann Arbor, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2022
- FDA classified
- 8 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 21 Jan 2022 | Recall initiated by company | |
| 8 Mar 2022 | Classified by FDA | +46 days |
| 16 Mar 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of FL, MD, MI, NY.
Questions about this recall
Is NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled?
Yes. NeuMoDx Molecular recalled NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip on 21 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0738-2022.
Why was it recalled?
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Which lots are affected?
Lot: 116305 S/L-02 (Sublot 02),UDI: 10814278020830
Where was it sold?
US Nationwide distribution in the states of FL, MD, MI, NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from NeuMoDx Molecular
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NeuMoDx Cartridge-used for extraction, purification recalled | NeuMoDx Molecular | Other | Nationwide |
| Device | CLASS III | NeuMoDx Sars-CoV-2 Assay -Ivd intended recalled by NeuMoDx Molecular | NeuMoDx Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip recalled | NeuMoDx Molecular | Lead & Heavy Metals | 10 states |
| Device | CLASS II | NeuMoDx Cartridge-For in vitro diagnostic use recalled | NeuMoDx Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | NeuMoDx Cartridge, For In Vitro Diagnostic Use on recalled | NeuMoDx Molecular | Potency & Assay | MI |
Other Insulin Pumps & Glucose Monitors recalls
All 459| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Other | Nationwide |
| Device | CLASS II | MiniMed Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Lead & Heavy Metals | Nationwide |
| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Lead & Heavy Metals | Nationwide |