Recall Z-0738-2022— NeuMoDx Molecular Inc
Class II · Ongoing
Class II FDA medical device recall by NeuMoDx Molecular Inc, initiated 2022-01-21. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- NeuMoDx Molecular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-21
- Firm location
- Ann Arbor, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.