Synchron Lx 20 Clinical Chemistry System, Synchron Lx Albumin Reagent, Synchron Lx Creatinine Picric Reagent, Synchron L

• • Terminated Z-2130-2011 FDA Unclassified (pre-2012) ·initiated 5 Apr 2011

  The recall was initiated because Beckman Coulter has received reports of incorrect electrolyte results on Synchron LX systems due to a variety of maintenance-related hardware issues.

• • Terminated Z-2071-2011 FDA Unclassified (pre-2012) ·initiated 22 Oct 2010

  This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.

• • Terminated Z-1951-2013 FDA Class II ·initiated 22 Sep 2010 ·on shared 510(k) K965240

  Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.

• • Terminated Z-1619-2011 FDA Unclassified (pre-2012) ·initiated 10 Aug 2010 ·on shared 510(k) K965240

  The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) Other hemolysed samples may be similar

• • Terminated Z-2389-2010 FDA Unclassified (pre-2012) ·initiated 2 Aug 2010 ·on shared 510(k) K965240

  The recall was initiated after Beckman Coulter confirmed reports that black / brown particulates were observed in some bottles of the Creatinine Alkaline Buffer (Buffer lot M911427 and M911518) in modular Creatinine (CREm) reagent kit lots M911428 and M911519. Beckman Coulter have had reports of erroneous results when using the lots of Creatinine Alkaline Buffer listed above. Single creatinine d

• • Terminated Z-2388-2010 FDA Unclassified (pre-2012) ·initiated 15 Apr 2010 ·on shared 510(k) K965240

  UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.

• • Terminated Z-1094-2008 FDA Unclassified (pre-2012) ·initiated 5 Apr 2007

  Intermittent Failure of Stirrer Motor-Beckman Coulter has determined that incorrect Glucose results on LX20 or DxC instruments have been related to an intermittent failure of the stirrer motor. -Stirrer motors can stall without any flags or motion errors. -If a stall occurs during a GLUm test near the time of sample inject, results may be affected. -Affected GLUm results may be high or low.

• • Terminated Z-0009-06 FDA Unclassified (pre-2012) ·initiated 6 Sep 2005

  Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.

• • Terminated Z-1098-04 FDA Unclassified (pre-2012) ·initiated 10 Oct 2003 ·on shared 510(k) K965240

  Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.

• • Terminated Z-1116-04 FDA Unclassified (pre-2012) ·initiated 7 Oct 2003 ·on shared 510(k) K965240

  'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.

• • Terminated Z-0096-04 FDA Unclassified (pre-2012) ·initiated 18 Sep 2003 ·on shared 510(k) K965240

  Sample wheel may home to the wrong position.

• • Terminated Z-0545-03 FDA Unclassified (pre-2012) ·initiated 16 Dec 2002 ·on shared 510(k) K965240

  The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K965240 ↗

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. →