Abbott Cell-Dyn 4000 System

• • Terminated Z-1623-2011 FDA Unclassified (pre-2012) ·initiated 29 Dec 2009

  A component used in assembly is out of specification, resulting in failure to retract, eject specimens, exposure below the safety zone, piercing of specimen tubes, or error message to display.

• • Terminated Z-1103-2008 FDA Unclassified (pre-2012) ·initiated 19 Dec 2007 ·on shared 510(k) K961439

  Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.

• • Terminated Z-0565-2007 FDA Unclassified (pre-2012) ·initiated 22 Dec 2006 ·on shared 510(k) K961439

  Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.

• • Terminated Z-0708-2007 FDA Unclassified (pre-2012) ·initiated 17 Apr 2006 ·on shared 510(k) K961439

  High platelet background count when using the CELL-DYN 4000 System and/or CELL-DYN Sapphire System; with patient results unacceptable -out-of-range.

• • Terminated Z-0639-2007 FDA Unclassified (pre-2012) ·initiated 12 May 2004 ·on shared 510(k) K961439

  Incorrect Test Results-test results may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

• • Terminated Z-0640-2007 FDA Unclassified (pre-2012) ·initiated 24 Feb 2004 ·on shared 510(k) K961439

  Incorrect Test Results-product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).

• • Terminated Z-0648-03 FDA Unclassified (pre-2012) ·initiated 16 Oct 2002

  Product elicits fluorescent signal interference due to contamination.

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

510(k) Number

K961439 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Cell-Dyn 3000 Multi-Parameter Hematology Analyer

  Class II

  FDA 510(k) K890491 Active Cleared 18 Apr 1989

• Model 340 Spectrophotometer

  Class I

  FDA 510(k) K822720 Active Cleared 8 Oct 1982

• Cell Dyn 800 Hematology Analyzer

  Class II

  FDA 510(k) K803218 Active Cleared 9 Jun 1981

• Cell-Dyn 2000 Automated Multi-Parameter Hematology

  Class II

  FDA 510(k) K852371 Active Cleared 17 Sep 1985

• Cell-Dyn Rapid-Lyse and Hemogloblin

  Class II

  FDA 510(k) K881242 Active Cleared 21 Apr 1988

• Cell-Dyn Brand Hematology Reagents

  Class II

  FDA 510(k) K852372 Active Cleared 3 Sep 1985

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