NeuMoDx Molecular Inc: Medical Device Recall in 2023 - (Recall #: Z-2093-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

Product Classification:

Class III

Date Initiated: May 15, 2023

Date Posted: July 12, 2023

Recall Number: Z-2093-2023

Event ID: 92490

Reason for Recall:

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

Status: Ongoing

Product Quantity: 1,086 test strips

Code Information:

GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023

Distribution Pattern:

US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.

Voluntary or Mandated:

Voluntary: Firm initiated