Bacton Dickinson Latitude Blood Glucose Monitoring System

• • Terminated Z-0561-06 FDA Unclassified (pre-2012) ·initiated 5 Jan 2006 ·on shared 510(k) K022580

  BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.

• • Terminated Z-0763-04 FDA Unclassified (pre-2012) ·initiated 29 Jan 2004 ·on shared 510(k) K022580

  39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

• • Terminated Z-1221-03 FDA Unclassified (pre-2012) ·initiated 23 Jul 2003 ·on shared 510(k) K022580

  Test Strips may not be meeting specifications at the lower range of glucose values.

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

510(k) Number

K022580 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

  Class II

  FDA 510(k) K030677 Active Cleared 1 Apr 2003

• BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

  Class II

  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

  Class II

  FDA 510(k) K090827 Active Cleared 27 May 2009

• Bd Pen Needle

  Class II

  FDA 510(k) K051899 Active Cleared 13 Sep 2005

• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

See all devices from Becton, Dickinson & Co. →