Irma Blood Analysis System

• 2 recalls, same reason

  • Terminated Z-0160-2016 FDA Class II ·initiated 16 Sep 2015
  • Terminated Z-0159-2016 FDA Class II ·initiated 16 Sep 2015

  May report values outside the published performance specifications for pH. After a certain point in shelf life, the pH sensor may give results that are falsely elevated. The discrepancy is greater as shelf life progresses and can be seen on the aqueous controls before the blood.

• • Terminated Z-1919-2015 FDA Class II ·initiated 29 Apr 2015

  The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will drift over time.

• • Terminated Z-1072-03 FDA Unclassified (pre-2012) ·initiated 14 Jul 2003 ·on shared 510(k) K945240

  An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.

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

510(k) Number

K945240 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Irma Blood Analysis System with Optional Lifescan Surestep Pro Blood Glucose Module

  Class II

  FDA 510(k) K974396 Active Cleared 18 Dec 1997

• Trendcare Calibrator Model Scu 7007

  Class II

  FDA 510(k) K983198 Active Cleared 23 Nov 1999

• Neurotrend Multiparameter Sensor, C7004S, to Operate with Paratrend 7+ Multiparameter Sensor, MPM7001S, and Satellite Ms

  Class II

  FDA 510(k) K980380 Active Cleared 14 Jul 1999

• Paratrend 7 Neotrend Multiparameter/Sensor with Paratrend 7 Multiparameter Senior and Satellite Monitor System

  Class II

  FDA 510(k) K972314 Active Cleared 19 Dec 1997

• Irma Blood Analysis System

  Class II

  FDA 510(k) K981270 Active Cleared 1 May 1998

• Irma Sl Blood Analysis System Gl Cartridge

  Class I

  FDA 510(k) K011586 Active Cleared 16 Nov 2001

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