Coulter(R) MH010

• • Terminated Z-1731-2011 FDA Unclassified (pre-2012) ·initiated 14 Dec 2010

  The recall was initiated because Beckman Coulter has confirmed the Coulter MAXM, MAXM AL, HmX and HmX AL Analyzers omit the tilde (~) character when the tilde is used as part of the Sample 10 within a barcode label scanned by the primary mode barcode reader. There is a potential for Specimen or Patient misidentification to occur.

510(k) Number

K911385 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Retic-C Cell Control

  Class II

  FDA 510(k) K930119 Active Cleared 5 Apr 1993

• Coulter Uric Acid Reagent

  Class I

  FDA 510(k) K897161 Active Cleared 1 Mar 1990

• Coulter Direct Billrubin Reagent

  Class II

  FDA 510(k) K905622 Active Cleared 26 Dec 1990

• Coulter Counter-Blood Cell Counter

  Class II

  FDA 510(k) K792668 Active Cleared 29 Jan 1980

• Coulter Total Protein Reagent

  Class II

  FDA 510(k) K897166 Active Cleared 23 Feb 1990

• Chemistry, Coulter

  Class I

  FDA 510(k) K770679 Active Cleared 3 May 1977

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