I-Stat Portable Clinical Analyzer, Model 300

• 6 recalls, same reason

  • Terminated Z-1974-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)
  • Terminated Z-1978-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)
  • Terminated Z-1973-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)
  • Terminated Z-1976-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)
  • Terminated Z-1975-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)
  • Terminated Z-1977-2012 FDA Class II ·initiated 8 Sep 2011 ·via K001387, on the same 510(k)

  Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

• 2 recalls, same reason

  • Terminated Z-0598-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010
  • Terminated Z-0597-2011 FDA Unclassified (pre-2012) ·initiated 20 Sep 2010

  i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.

• • Terminated Z-2462-2010 FDA Unclassified (pre-2012) ·initiated 20 Aug 2010

  Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.

• • Terminated Z-1133-2010 FDA Unclassified (pre-2012) ·initiated 6 Nov 2009

  Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.

• • Terminated Z-0865-2010 FDA Unclassified (pre-2012) ·initiated 29 Sep 2009 ·via K001387, on the same 510(k)

  Abbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of comment being included in the CDS test record only.

• • Terminated Z-0812-2010 FDA Unclassified (pre-2012) ·initiated 9 Sep 2009

  The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.

• • Terminated Z-2328-2009 FDA Unclassified (pre-2012) ·initiated 22 Apr 2009

  It appears that the rechargeable battery pack is overheating with or without the presence of smoke.

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

510(k) Number

K001387 ↗

FDA Product Code

CGA

Device Class

Class II

Regulation

21 CFR Part 862.1345

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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