Dsl 7800 Active Cortisol

• • Terminated Z-2761-2011 FDA Unclassified (pre-2012) ·initiated 20 Jul 2009

  The recall was initiated because Beckman Coulter has confirmed that the listed lot numbers of Active Control ELISA reagent will result in falsely high values for patient samples due to a shift in the calibration of the assigned standard values. Beckman Coulter recommends that patient results, generated with the affected lots, be evaluated in the context of other diagnostic tests and the clinica

510(k) Number

K884689 ↗

FDA Product Code

CGR

Device Class

Class II

Regulation

21 CFR Part 862.1205

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K915823 Active Cleared 17 Mar 1992

• Active T3 Ria

  Class II

  FDA 510(k) K960550 Active Cleared 6 Mar 1996

• Dsl Beta 2 Microglobulin (Dsl 6200)

  Class II

  FDA 510(k) K911881 Active Cleared 10 Sep 1991

• Active Crosslaps Elisa

  Class I

  FDA 510(k) K960171 Active Cleared 28 Mar 1996

• Dsl Aactive Dhea Eia Kit

  Class I

  FDA 510(k) K955114 Active Cleared 23 Feb 1996

• Dsl Insulin Ria (Dsl 1600)

  Class I

  FDA 510(k) K914820 Active Cleared 9 Jan 1992

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