Bactec Plus Aerobic/F and Anaerobic/F Media

• 4 recalls, same reason

  • Terminated Z-1008-2010 FDA Unclassified (pre-2012) ·initiated 11 Nov 2009
  • Terminated Z-1010-2010 FDA Unclassified (pre-2012) ·initiated 11 Nov 2009
  • Terminated Z-1009-2010 FDA Unclassified (pre-2012) ·initiated 11 Nov 2009
  • Terminated Z-1011-2010 FDA Unclassified (pre-2012) ·initiated 11 Nov 2009

  The draw volume on test tubes of blood culture medium is marked with graduations that may be confusing for healthcare practitioners using the tubes for appropriate collection of patient samples for microbiological laboratory testing.

510(k) Number

K921133 ↗

FDA Product Code

MDB

Device Class

Class I

Regulation

21 CFR Part 866.2560

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Delta Test Triglycerides

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See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →