NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and or

FDA device recall Z-2093-2023 · posted 2023-07-05 · Open, Classified

Recall details

Recalling firm

NeuMoDx Molecular Inc

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.

Action taken

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

Root cause

Labeling mix-ups

Status

Open, Classified

Product code

QJR

Quantity affected

1,086 test strips

Distribution

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

Date initiated

2023-05-15

Date posted

2023-07-05

Location

Ann Arbor, MI