Immage System Rheumatoid Factor (Rf) Reagent

• • Terminated Z-0003-2013 FDA Class II ·initiated 27 Jan 2012

  The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.

• • Terminated Z-2887-2011 FDA Unclassified (pre-2012) ·initiated 31 May 2011

  The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.

510(k) Number

K963048 ↗

FDA Product Code

DHR

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

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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