Binaxnow Influenza a & B Test

• 2 recalls, same reason

  • Terminated Z-0822-2007 FDA Unclassified (pre-2012) ·initiated 28 Mar 2007 ·on shared 510(k) K062109
  • Terminated Z-0823-2007 FDA Unclassified (pre-2012) ·initiated 28 Mar 2007 ·on shared 510(k) K062109

  Tip of the foam swab could detach from the shaft causing injury to the patient.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K062109 ↗

FDA Product Code

PSZ

Device Class

Class II

Regulation

21 CFR Part 866.3328

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Binax Now Streptococcus Pneumoniae Test Open recall

  Class I

  FDA 510(k) K012521 Active Cleared 30 Nov 2001

• Binax Now Rsv Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065

  Class I

  FDA 510(k) K032166 Active Cleared 21 Oct 2003

• Binaxnow PBP2A Test, Model 890-000

  Class II

  FDA 510(k) K090301 Active Cleared 14 Apr 2010

• Binax Equate Strep B

  Class I

  FDA 510(k) K872904 Active Cleared 20 Nov 1987

• Binaxnow Influenza a & B Test

  Class II

  FDA 510(k) K053126 Active Cleared 30 Nov 2005

• Equate AQR APO AL/B Duo Control

  Class II

  FDA 510(k) K903122 Active Cleared 2 Aug 1990

See all devices from Binax, Inc. →