Synchon Cx Delta Clin Syst (CX4, CX5, CX7 Delta)

• 4 recalls, same reason

  • Terminated Z-0128-2012 FDA Unclassified (pre-2012) ·initiated 23 Aug 2010
  • Terminated Z-0125-2012 FDA Unclassified (pre-2012) ·initiated 23 Aug 2010
  • Terminated Z-0132-2012 FDA Unclassified (pre-2012) ·initiated 23 Aug 2010
  • Terminated Z-0131-2012 FDA Unclassified (pre-2012) ·initiated 23 Aug 2010

  The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.

510(k) Number

K950958 ↗

FDA Product Code

JJE

Device Class

Class I

Regulation

21 CFR Part 862.2160

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

See all devices from Beckman Instruments, Inc. →