Iri Spec Urinalysis Control

• • Terminated Z-1328-2013 FDA Class II ·initiated 18 Sep 2012

  The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.

510(k) Number

K832713 ↗

FDA Product Code

JJW

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Iris Urine Stain

  Class I

  FDA 510(k) K821503 Active Cleared 3 Jun 1982

• 939UDX Urine Pathology System

  Class II

  FDA 510(k) K000373 Active Cleared 14 Apr 2000

• The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability

  Class II

  FDA 510(k) K934539 Active Cleared 30 Mar 1994

• Iq 200 System Open recall

  Class II

  FDA 510(k) K022774 Active Cleared 21 Oct 2002

• Iristain Formula 2, Parts 1 and 2

  Class I

  FDA 510(k) K893530 Active Cleared 13 Jun 1989

• Yellow Iris Urinalysis Wrksta W/Iriscope Bdy Flu

  Class II

  FDA 510(k) K914256 Active Cleared 1 May 1992

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