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U.S. Department of Health and Human Services

Class 3 Device Recall NeuMoDx SARSCoV2 Assay

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  Class 3 Device Recall NeuMoDx SARSCoV2 Assay see related information
Date Initiated by Firm May 15, 2023
Date Posted July 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-2093-2023
Recall Event ID 92490
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
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
Code Information GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Recalling Firm/
NeuMoDx Molecular Inc
1250 Eisenhower Pl
Ann Arbor MI 48108-3281
For Additional Information Contact SAME
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.