FDA Medical Device Recalls (openFDA)
Princeton Biomeditech Corp: 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.
- Recall number
- Z-2306-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-03-09
- Posted
- 2012-08-31
- Terminated
- 2014-10-14
- Reason
- There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
- 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
- 370 (12 tests per kit) ;2800 kits (22 tests per kit)
- Distribution
- Nationwide Distribution-including the states of NJ, NY, and PA.
- Lot, serial or model codes
- 510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits
- 510(k) numbers
- ["K083746"]
- PMA numbers
- not on file
- Product code
- GNX
- Firm FEI
- 2246703
- Firm city
- Monmouth Junction
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28