FDA Medical Device Recalls (openFDA)
NeuMoDx Molecular Inc: 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
- Recall number
- Z-2093-2023
- 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
- Status
- Open, Classified
- Initiated
- 2023-05-15
- Posted
- 2023-07-05
- Terminated
- not on file
- Reason
- 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
- 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
- 1,086 test strips
- Distribution
- US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
- Lot, serial or model codes
- GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QJR
- Firm FEI
- 3010729479
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28