Access Estradiol Reagents on the Access Immunoassay Analyzer

• • Terminated Z-0448-2011 FDA Unclassified (pre-2012) ·initiated 4 Mar 2010

  The recall was initiated after Beckman Coulter confirmed that three lots of Access Estradiol reagent (REF 33540) contains an incorrect raw material which may produce incorrect patient results.

• • Terminated Z-0872-03 FDA Unclassified (pre-2012) ·initiated 8 May 2003

  Short volume, resulting possibility of falsely elevated results.

510(k) Number

K973743 ↗

FDA Product Code

CHP

Device Class

Class I

Regulation

21 CFR Part 862.1260

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Beckman Hdl Cholesterol Reagent

  Class I

  FDA 510(k) K934045 Active Cleared 14 Oct 1993

• Beckman Urine Protein Calibrator (Ucal)

  Class II

  FDA 510(k) K973928 Active Cleared 1 Dec 1997

• Beckman Uric Acid Reagent

  Class I

  FDA 510(k) K821812 Active Cleared 2 Jul 1982

• Immage Immunochemistry System Alpha-2-Macroglobulin Reagent

  Class II

  FDA 510(k) K974564 Active Cleared 17 Feb 1998

• Immage Immunochemistry System Ceruloplasmin (Cer) Reagent

  Class II

  FDA 510(k) K964762 Active Cleared 25 Apr 1997

• Immage Immunochemistry System Haptoglobin (Hpt) Reagent

  Class II

  FDA 510(k) K963286 Active Cleared 7 Oct 1996

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