PlainRecalls
FDA Devices Moderate Class II Terminated

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 infection

Reported: September 12, 2012 Initiated: March 9, 2012 #Z-2308-2012

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.

Details

Units Affected
90 kits (22 tests per kit)
Distribution
Nationwide Distribution-including the states of NJ, NY, and PA.
Location
Monmouth Junction, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Princeton Biomeditech Corp. Units affected: 90 kits (22 tests per kit).
Why was this product recalled? ▼
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Moderate. Recall number: Z-2308-2012.

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