Cell-Dyn 1600 Multiparameter Auto. Hema. Analyzer

• • Terminated Z-1698-2011 FDA Unclassified (pre-2012) ·initiated 30 Nov 2009

  The use of the device assemblies has been extended to a 6 month useful life.

• 2 recalls, same reason

  • Terminated Z-1628-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2009
  • Terminated Z-1629-2010 FDA Unclassified (pre-2012) ·initiated 8 Jun 2009

  Use of Syringe LN 04H36-01 with the Die-cast syringe drive may result in leakage, leading to delay in reporting patient results.

• 2 recalls, same reason

  • Terminated Z-1171-2007 FDA Unclassified (pre-2012) ·initiated 16 May 2007
  • Terminated Z-1170-2007 FDA Unclassified (pre-2012) ·initiated 16 May 2007

  Abnormal results may not be "flagged" appropriately because of a software anomaly. (Flags for the Hemoglobin (HGB), MCH and MCHC parameters when the upper assay paramter limit has been exceeded)

510(k) Number

K870233 ↗

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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