NeuMoDx Molecular Inc: Medical Device Recall in 2022 - (Recall #: Z-1000-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 18, 2022

Date Posted: May 4, 2022

Recall Number: Z-1000-2022

Event ID: 89846

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

Status: Ongoing

Product Quantity: 773 (72 US and 701 ROW) cases (48 cartridges/case)

Code Information:

Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated