Bact/Alert (Tm)

• • Terminated Z-0644-2007 FDA Unclassified (pre-2012) ·initiated 19 Dec 2006

  Bottle data is not sent to BacT/ALERT 3D instrument.

• • Terminated Z-0773-2007 FDA Unclassified (pre-2012) ·initiated 14 Aug 2006

  Plastic bottle samples assigned less sensitive default glass bottle algorithm instead of the plastic bottle algorithm on BacT/ALERT Microbial Detection Systems.

• 3 recalls, same reason

  • Terminated Z-0614-05 FDA Unclassified (pre-2012) ·initiated 27 May 2005
  • Terminated Z-0613-05 FDA Unclassified (pre-2012) ·initiated 27 May 2005
  • Terminated Z-0612-05 FDA Unclassified (pre-2012) ·initiated 27 May 2005

  A Bac T/ALERT 3D system failed to detect a positive sample in a pediatric BAC T/ALERT PF bottle.

• • Terminated Z-0456-05 FDA Unclassified (pre-2012) ·initiated 17 Sep 2004

  Over heating of memory board.

510(k) Number

K903505 ↗

FDA Product Code

MDB

Device Class

Class I

Regulation

21 CFR Part 866.2560

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Fibrinostika Tdp Microelisa System

  Class II

  FDA 510(k) K915698 Active Cleared 5 Aug 1992

• Nephross I.Q. Andante

  Class II

  FDA 510(k) K874549 Active Cleared 29 Jan 1988

• Mda Protein Assay

  Class II

  FDA 510(k) K925617 Active Cleared 27 Jan 1994

• Bsm 2000 Dialysis Machine

  Class II

  FDA 510(k) K840062 Active Cleared 22 Mar 1984

• Bact/Alert Culture Bottles

  Class I

  FDA 510(k) K973305 Active Cleared 17 Nov 1997

• Nuclisens Cmv PP67

  Class II

  FDA 510(k) K983762 Active Cleared 15 Sep 1999

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