Recall Z-1251-2022— NeuMoDx Molecular Inc
Class II · Ongoing
Class II FDA medical device recall by NeuMoDx Molecular Inc, initiated 2022-05-13. 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, Model No. 300900. Reason: There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment..
- Recalling firm
- NeuMoDx Molecular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-13
- Firm location
- Ann Arbor, MI, United States
Product description
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
Reason for recall
There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and delaying appropriate treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.