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Open, Classified

NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

FDA Recall Z-0738-2022 · Posted None

Recalling FirmNeuMoDx Molecular Inc
Recall StatusOpen, Classified
Product CodeQJR
Date Initiated2022-01-21
Product Quantity102 boxes

Reason for Recall

A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

Firm Action

Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of FL, MD, MI, NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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