I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set

• 2 recalls, same reason

  • Terminated Z-1864-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2010
  • Terminated Z-1863-2011 FDA Unclassified (pre-2012) ·initiated 17 Dec 2010

  Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration Verification Set.

510(k) Number

K031873 ↗

FDA Product Code

JJX

Models / Variants

I-Stat Cardiac Markers Control Level 1, 2, And 3

Cardiac Markers Calibration Verification Control Set

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

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