# FDA recall Z-1000-2022

> **NeuMoDx Molecular Inc** · Class II · device recall initiated 2022-02-18.

## 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-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

## 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

## Distribution

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.

## Key facts

- **Recall number:** Z-1000-2022
- **Recalling firm:** NeuMoDx Molecular Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-18
- **Report date:** 2022-05-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ann Arbor, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1000-2022

## Citation

> AI Analytics. FDA recall Z-1000-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1000-2022. Source: US FDA. Licensed CC0.

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