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.
Reported: March 16, 2022 Initiated: January 21, 2022 #Z-0738-2022
Product Description
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.
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.
Details
- Recalling Firm
- NeuMoDx Molecular Inc
- Units Affected
- 102 boxes
- Distribution
- US Nationwide distribution in the states of FL, MD, MI, NY.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by NeuMoDx Molecular Inc. Units affected: 102 boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0738-2022.
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