NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative… recallZ-2093-2023 · NeuMoDx Molecular Inc · initiated May 15, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from NeuMoDx Molecular Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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
Recall details
- Recall number
- Z-2093-2023
- Status
- Open, Classified
- Initiated by the company
- May 15, 2023
- Posted by the FDA
- Jul 5, 2023
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 1,086 test strips
- Product code
- QJR
- Distribution
- US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
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
Code information (models, lots, serial numbers)
GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NeuMoDx SARS-CoV-2 Test Strip 300800Neumodx Molecular, Inc. · Reagents, 2019-Novel Coronavirus Nucleic Acid1 recall38 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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