CLASS II ONGOING Device recall · Reported 15 Jun 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 in 10 states. The recall was initiated on 13 May 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-1251-2022
- FDA event ID
- 90275
- Recalling firm
- NeuMoDx Molecular, Ann Arbor, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 May 2022
- FDA classified
- 8 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 13 May 2022 | Recall initiated by company | |
| 8 Jun 2022 | Classified by FDA | +26 days |
| 15 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Where it was distributed
Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
DelawareFloridaIdahoMarylandMichiganNew MexicoNew YorkPennsylvaniaTennesseeVirginia
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 13 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1251-2022.
Why was it recalled?
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Which lots are affected?
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508
Where was it sold?
Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
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 Cartridge-For in vitro diagnostic use recalled | NeuMoDx Molecular | Potency & Assay | Nationwide |
| Device | CLASS II | NeuMoDx Flu A-B/RSV/Sars-CoV-2 Vantage Test Strip 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 |