Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791

• 2 recalls, same reason

  • Terminated Z-1536-2020 FDA Class II ·initiated 13 Feb 2020
  • Terminated Z-1538-2020 FDA Class II ·initiated 13 Feb 2020

  Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

510(k) Number

K053132 ↗

FDA Product Code

JFM

Models / Variants

996-23591

412-22901

992-23691

998-23791

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Wako Direct Bilirubin V

  Class II

  FDA 510(k) K970986 Active Cleared 7 May 1997

• Wako Autokit CH50

  Class II

  FDA 510(k) K954145 Active Cleared 18 Dec 1995

• Wako Total Bilirubin V

  Class II

  FDA 510(k) K970985 Active Cleared 21 Apr 1997

• Wako Nefa Linearity Set

  Class I

  FDA 510(k) K030065 Active Cleared 11 Feb 2003

• Total Bilirubin Standard Calibrator

  Class II

  FDA 510(k) K872263 Active Cleared 22 Jul 1987

• Wako Autokit Apo A1

  Class I

  FDA 510(k) K952615 Active Cleared 8 Sep 1995

See all devices from Wako Chemicals USA, Inc. →