Synchron Lx Systems Immunoglobulin G/a/M Reagent

• • Terminated Z-2226-2011 FDA Unclassified (pre-2012) ·initiated 11 Mar 2011 ·on shared 510(k) K965108

  The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558. During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been re

• • Terminated Z-2653-2010 FDA Unclassified (pre-2012) ·initiated 28 Jun 2010

  The recall was initiated after Beckman Coulter Inc. confirmed reports of high recovery of immunoglobulin A (IgA) in proficiency surveys or patient samples using Synchron Ig-A reagent lots M812164 or M902345. Using these reagent lots, some samples deficient in IgA have yielded results in the normal range. Other samples with normal levels of IgA have yielded falsely high results.

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

510(k) Number

K965108 ↗

FDA Product Code

DEW

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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