NeuMoDx Molecular Inc: 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/

Is my product affected?

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: Res

• UPC 10814278020274

Check against the official notice below — it lists the full affected range.

What happened

NeuMoDx Molecular Inc. is recalling NeuMoDx Cartridges used with NeuMoDx Molecular Systems for SARS-CoV-2 testing. The cartridges in certain lots have the potential to produce false positive results for SARS-CoV-2 when used with the NeuMoDx SARS-CoV-2 Test Strip or the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, which could lead to incorrect patient management. The affected product was distributed worldwide, including throughout the United States in Ohio, Missouri, Virginia, Michigan, Florida, Maryland, Iowa, and New York, as well as in multiple European countries and Hong Kong.

The recall involves 773 cases (72 cases in the US and 701 cases internationally) containing a total of 36,096 cartridges. The affected lot numbers are 115424, 115425, 115426, 115427, 115429, and 115431. The source document does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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. Quantity: 773 (72 US and 701 ROW) cases (48 cartridges/case) Lot/code info: Lot Numbers: 115424, 115425, 115426, 115427, 115429, 115431. GTIN: 10814278020274

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Signa 1.5T TwinSpeed Magnetic Resonance Imaging System2022-02-18
• 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System2022-02-18
• SIGNA Excite 3T. Magnetic Resonance Imaging System2022-02-18
• 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System2022-02-18
• Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product C2022-02-18

All FDA (Device enforcement) recalls