Z-2306-2012Class II

Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The...

Name: Z-2306-2012 Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The...
Creator: Princeton Biomeditech Corp
Published: 2012-03-09
License: https://open.fda.gov/license/

Princeton BioMeditech Corp. / initiated 2012-03-09 / Terminated / root cause: manufacturing process

FDA source

Princeton Biomeditech Corp began a recall of Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative... on 2012-03-09. FDA classified it as Class II and gives the reason as "There have been reports of dual positive (Flu A + Flu B positive) results being encountered". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2306-2012
Classification: Class II
Status: Terminated
Initiated: 2012-03-09
Posted: 2012-08-31
Terminated: 2014-10-14
Recalling firm: Princeton BioMeditech Corp.
Product: Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 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 code: GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Reason for recall: There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: OraSure Technologies, Inc. sent an "IMPORTANT NOTICE FOR ORASURE QUICKFLU RAPID FLU A + B TEST" letter dated March 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact the firm at 610-882-1820 for questions concerning this recall.
Quantity in commerce: 370 (12 tests per kit) ;2800 kits (22 tests per kit)
Distribution: Nationwide Distribution-including the states of NJ, NY, and PA.
Product codes and lots: 510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2306-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2306-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31
Z-2307-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31
Z-2308-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31

Product code GNX

K083746Class IIBiosign Flu A+bPrinceton BioMeditech Corp. / cleared 2010-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)