Z-1251-2022 Class II Ongoing
FDA device recall Z-1251-2022 was initiated by NeuMoDx Molecular Inc on May 13, 2022 and is designated Class II. 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 transmiss… The recall status is ongoing. Affected quantity: 459 kits US; 1626 kits OUS.
Recall Details
- Product Type
- Devices
- Report Date
- June 15, 2022
- Initiation Date
- May 13, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 459 kits US; 1626 kits OUS
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.
Distribution Pattern
Domestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution to AT, AU, BE, CH, DE, FI, FR, GB, GR, HK, ID, IT, LT, NL, SA, SE, and SI.
Code Information
UDI-DI (GTIN): 10814278020830 Cartridge lot numbers 111915 - 117508