Ready Sensor™ GOLD pH Sensor 10376877

• 2 recalls, same reason

  • Terminated Z-2929-2018 FDA Class II ·initiated 16 Jul 2018
  • Terminated Z-2930-2018 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-2040-2017 FDA Class II ·initiated 10 Apr 2017

  Potential Patient Demographic Error with Blank Patient ID Field

• 2 recalls, same reason

  • Terminated Z-2801-2016 FDA Class II ·initiated 11 Aug 2016
  • Terminated Z-2800-2016 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-1961-2015 FDA Class II ·initiated 6 May 2015

  D50 and D51 Diagnostic error codes are not functional.

• 2 recalls, same reason

  • Terminated Z-0106-2014 FDA Class II ·initiated 17 Sep 2012
  • Terminated Z-0105-2014 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-1464-06 FDA Unclassified (pre-2012) ·initiated 4 Apr 2006
  • Terminated Z-1465-06 FDA Unclassified (pre-2012) ·initiated 4 Apr 2006

  Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm™ data management system.

• 4 recalls, same reason

  • Terminated Z-0684-06 FDA Unclassified (pre-2012) ·initiated 20 Jan 2006
  • Terminated Z-0683-06 FDA Unclassified (pre-2012) ·initiated 20 Jan 2006
  • Terminated Z-0682-06 FDA Unclassified (pre-2012) ·initiated 20 Jan 2006
  • Terminated Z-0685-06 FDA Unclassified (pre-2012) ·initiated 20 Jan 2006

  When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1.0, 1.01, or 1.02. The correlation feature applies user-defined slope and offset parameters each time stored test results are recalled to the display.

Trade Name

Ready Sensor - pH EUDAMED

Ready Sensor™ GOLD pH Sensor GUDID

Generic Name

Blood pH electrode

Device Name

IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-RapidLab1200

Model / Ref / Catalog

10376877, IVDR_69_TTN_DUB-C_C_NPT_REAG_BG-RapidLab1200

Primary DI / UDI-DI

00630414570457

Basic UDI-DI

0405686901967WP

Unit of Use DI

00630414010175

510(k) Number

K031560 ↗

FDA Product Code

CEM, CHL, JFP, GKR, CGZ, KHP, CGA, JGS

EMDN Code

W0101060604 Ph/po2/pco2 - electrodes (bg)

GMDN Term

Blood pH electrode

Device Class

Class C EUDAMED

Class II GUDID

Regulation Number

862.1600, 862.1120, 862.1145, 864.5620, 862.1170, 862.1450, 862.1345, 862.1665

EU market of registration

Germany

GUDID distribution status

In Commercial Distribution

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