NeuMoDx Molecular Inc: Medical Device Recall in 2021 - (Recall #: Z-1978-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100

Product Classification:

Class II

Date Initiated: May 4, 2021

Date Posted: July 7, 2021

Recall Number: Z-1978-2021

Event ID: 88099

Reason for Recall:

There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.

Status: Terminated

Product Quantity: 620 cases (29,760 cartridges total)

Code Information:

GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated