I-Stat Model 100 Port Clin Analyzer & Test Pack

• 3 recalls, same reason

  • Terminated Z-1796-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·via K912387, on the same 510(k)
  • Terminated Z-1797-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·via K912387, on the same 510(k)
  • Terminated Z-1798-2010 FDA Unclassified (pre-2012) ·initiated 5 Feb 2010 ·via K912387, on the same 510(k)

  Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.

• • Terminated Z-1540-2009 FDA Unclassified (pre-2012) ·initiated 23 Feb 2009 ·via K912387, on the same 510(k)

  Equipment problem: i-STAT cartridges were not properly sealed as the packaging system jammed, causing compromised seals.

• 4 recalls, same reason

  • Terminated Z-0372-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0374-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0375-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007
  • Terminated Z-0371-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007

  Difficult to Close -- Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

• • Terminated Z-0370-2008 FDA Unclassified (pre-2012) ·initiated 18 Oct 2007

  Difficult to Close -- Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K912387 ↗

FDA Product Code

JGS

Device Class

Class II

Regulation

21 CFR Part 862.1665

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Modification to: I-Stat Portable Clinical Analyzer

  Class II

  FDA 510(k) K012478 Active Cleared 20 Aug 2001

• Model 100 Portable Clinical Analyzer and Test Pack

  Class II

  FDA 510(k) K894914 Active Cleared 16 Oct 1989

• I-Stat Control Levels 1, 2, 3

  Class I

  FDA 510(k) K934641 Active Cleared 9 Dec 1993

• I-Stat Tests for Acid-Base Parameters

  Class II

  FDA 510(k) K936081 Active Cleared 24 Feb 1994

• I-Stat B-Type Natriuretic Peptide (Bnp)

  Class II

  FDA 510(k) K053597 Active Cleared 21 Jul 2006

• I-Stat 200 Portable Clinical Analyzer Open recall

  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

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