Princeton Biomeditech Corp: Medical Device Recall in 2012 - (Recall #: Z-2308-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 9, 2012

Date Posted: September 12, 2012

Recall Number: Z-2308-2012

Event ID: 62537

Reason for Recall:

There have been reports of dual positive (Flu A + Flu B positive) results being encountered.

Status: Terminated

Product Quantity: 90 kits (22 tests per kit)

Code Information:

510 k K083746 Catalog Number 36022 Lot numbers 441H11 90 kits (22 tests per kit)

Distribution Pattern:

Nationwide Distribution-including the states of NJ, NY, and PA.

Voluntary or Mandated:

Voluntary: Firm initiated