Synchron Systems Carbamazepine Test System

• 2 recalls, same reason

  • Terminated Z-1173-2012 FDA Unclassified (pre-2012) ·initiated 11 Aug 2009 ·on shared 510(k) K955644
  • Terminated Z-1174-2012 FDA Unclassified (pre-2012) ·initiated 11 Aug 2009 ·on shared 510(k) K955644

  The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.

• • Terminated Z-2437-2010 FDA Unclassified (pre-2012) ·initiated 19 Feb 2009 ·on shared 510(k) K955644

  The reagent produces false low test results. Beckman Coulter has confirmed low recovery of values at the low end of the therapeutic range (<1.5 ug/mL, <3.13 umol/L) with SYNCHRON Systems Gentamicin Reagent (GEN) lot M804552. A false low result can cause a patient to receive more medication than necessary.

• • Terminated Z-0935-04 FDA Unclassified (pre-2012) ·initiated 11 Jun 2003

  Product was found to produce higher recoveries by about 7-12% compared to other lots.

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

510(k) Number

K955644 ↗

FDA Product Code

KLT

Device Class

Class II

Regulation

21 CFR Part 862.3645

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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