Bayer Rapidpoint 405 System

• 2 recalls, same reason

  • Terminated Z-2927-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-2928-2018 FDA Class II ·initiated 16 Jul 2018

  Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.

• • Terminated Z-2479-2015 FDA Class II ·initiated 28 Jul 2015 ·on shared 510(k) K020616

  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-0066-04 FDA Unclassified (pre-2012) ·initiated 26 Sep 2003 ·on shared 510(k) K020616

  Potential for bias shift in pO2 values due to air bubble in sample path

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

510(k) Number

K020616 ↗

FDA Product Code

GKR

Device Class

Class II

Regulation

21 CFR Part 864.5620

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Salicylate Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K020794 Active Cleared 11 Jul 2002

• Bayer Special Chemistry Controls

  Class I

  FDA 510(k) K033379 Active Cleared 19 Dec 2003

• Ammonia Assay for the Advia 1650

  Class I

  FDA 510(k) K023841 Active Cleared 24 Dec 2002

• Uric Acid Assay for the Advia Integrated Modular System

  Class I

  FDA 510(k) K022096 Active Cleared 18 Mar 2003

• Bayer Special Chemistry Calibrators

  Class II

  FDA 510(k) K033380 Active Cleared 16 Dec 2003

• Ca 15-3 Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K022178 Active Cleared 12 Nov 2002

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