Wako Autokit LP(a)

• • Terminated Z-1377-2012 FDA Not yet classified ·initiated 30 Jan 2012

  In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease.

• • Terminated Z-1409-06 FDA Unclassified (pre-2012) ·initiated 6 Jul 2006 ·on shared 510(k) K981446

  Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.

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

510(k) Number

K981446 ↗

FDA Product Code

DFC

Device Class

Class II

Regulation

21 CFR Part 866.5600

Advisory Committee

Immunology

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. →