CLASS II ONGOING Device recall · Reported 4 May 2022 · FDA Enforcement Report
NeuMoDx Cartridge-For in vitro diagnostic use recalled
NeuMoDx Molecular is recalling NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either, distributed nationwide in the US. The recall was initiated on 18 Feb 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-1000-2022
- FDA event ID
- 89846
- Recalling firm
- NeuMoDx Molecular, Ann Arbor, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Feb 2022
- FDA classified
- 22 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 18 Feb 2022 | Recall initiated by company | |
| 22 Apr 2022 | Classified by FDA | +63 days |
| 4 May 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
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 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
Where it was distributed
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.
Nationwide FloridaIowaMarylandMichiganMissouriNew YorkVirginia
Questions about this recall
Is NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either recalled?
Yes. NeuMoDx Molecular recalled NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either on 18 Feb 2022. The recall is Class II and its status is Ongoing. Recall number Z-1000-2022.
Why was it recalled?
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
Which lots are affected?
Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274
Where was it sold?
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.
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 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
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|---|---|---|---|---|---|
| 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 |