Dsl Active Igfbp-3 Irma (Dsl 6600)

• • Terminated Z-2607-2010 FDA Unclassified (pre-2012) ·initiated 9 Aug 2010

  The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF

510(k) Number

K950228 ↗

FDA Product Code

CFL

Device Class

Class I

Regulation

21 CFR Part 862.1370

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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