Z-2308-2012 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 12, 2012
- Initiation Date
- March 9, 2012
- Termination Date
- October 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 kits (22 tests per kit)
Product Description
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
Reason for Recall
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Distribution Pattern
Nationwide Distribution-including the states of NJ, NY, and PA.
Code Information
510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)