Bayer Rapidpoint 400 System

• • Ongoing Z-2230-2025 FDA Class II ·initiated 26 Jun 2025

  Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.

• • Terminated Z-2912-2016 FDA Class III ·initiated 2 Sep 2016 ·on shared 510(k) K002738

  Error in the value assignment for the Chloride calibrators in the RAPIDPoint 400 and RAPIDPoint 405 Measurement Cartridge

• • Terminated Z-2797-2016 FDA Class II ·initiated 11 Aug 2016

  There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system

• • Terminated Z-2479-2015 FDA Class II ·initiated 28 Jul 2015 ·on shared 510(k) K002738

  When both ports (Serial and Ethernet) are configured to transmit data, the data stream from one port could potentially affect the data stream from the other port causing the data management system to include either: duplicate data, missing data, or data from a different patient.

• • Terminated Z-0102-2014 FDA Class II ·initiated 17 Sep 2012

  RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample

• 2 recalls, same reason

  • Terminated Z-1019-2010 FDA Unclassified (pre-2012) ·initiated 30 Oct 2009
  • Terminated Z-1020-2010 FDA Unclassified (pre-2012) ·initiated 30 Oct 2009

  Software: Reference sensor failure may result in inaccurate pH reuslts

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

510(k) Number

K002738 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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