Z-2093-2023Class III

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal...

Name: Z-2093-2023 NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal...
Creator: NeuMoDx Molecular Inc
Published: 2023-05-15
License: https://open.fda.gov/license/

Neumodx Molecular, Inc. / initiated 2023-05-15 / Open, Classified / root cause: labeling and UDI

FDA source

NeuMoDx Molecular Inc began a recall of 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... on 2023-05-15. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2093-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-07-05
Recalling firm: Neumodx Molecular, Inc.
Product: 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 code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: QIAGEN issued Urgent: Medical Device Correction Letter (PROM-22155-001) on 5/15/23 via email to Lab Director/Manager, Medical Director, Risk Manager,Safety Officer. Letter states reason for recall, health risk and action to take: If you have remaining stock of SARS-CoV-2 Test Strips LOT 123909 REF 300800, do not use it. Please contact QIAGEN Technical Service for a free-of-charge replacement. " Dispose of the product LOT 123909 in accordance with your national and local safety and environmental regulations. " Review this notice with your laboratory/medical director. Important: Forward this information to all individuals and departments within your organization using the above listed cartridges. If you are not the end user, please forward this notice to the product end user. " Complete Acknowledgement of Receipt attached to this letter as soon as possible. Assay strips from LOT 123909 can be identified from the box label, pouch label, and/or assay strip label. If you have any questions or concerns, please contact your local QIAGEN Technical Service Department through any of the following QIAGEN Subsidiaries: https://www.qiagen.com/us/contact-us/globalcontacts/subsidiaries
Quantity in commerce: 1,086 test strips
Distribution: US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
Product codes and lots: GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2093-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2093-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-05

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)