RAPIDLab® 1200 Series 1240 10321840Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414515540), received between Jul 27, 2020 and Jul 27, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Non Reproducible Results” (1 report).

14 other recalls cover devices cleared under the same FDA submission (K031560); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT PH VALUES ON THE RL 1240 BLOOD GAS ANALYZER. THE MOTHER HAS UNDERGONE A CAESAREAN SECTION. THE CUSTOMER WAS ASKED TO CONFIRM THE UNNECESSARY TREATMENT WAS NOT PERFORMED BECAUSE OF THE DISCREPANT RESULTS. THE CUSTOMER STATED THEY USED OTHER DIAGNOSTIC METHODS IN ADDITION, SUCH AS CARDIOTOCOGRAPHY, A FETAL MONITOR. THE CUSTOMER STATED THE BABY WAS BORN IN GOOD CONDITION.

  Patient problems: Pregnancy

  MAUDE report 10325956 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031560. One submission often covers many models, so check the product and lot details in each record.

• Z-2929-2018 · Jul 16, 2018 · Terminated
  RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood
• Z-2930-2018 · Jul 16, 2018 · Terminated
  RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes bloo
• Z-2040-2017 · Apr 10, 2017 · Terminated
  RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, to
• Z-2801-2016 · Aug 11, 2016 · Terminated
  RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
• Z-2800-2016 · Aug 11, 2016 · Terminated
  Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
• Z-1961-2015 · May 6, 2015 · Terminated
  The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood
• Z-0106-2014 · Sep 17, 2012 · Terminated
  Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professio
• Z-0105-2014 · Sep 17, 2012 · Terminated
  Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare profession
• Z-1464-06 · Apr 4, 2006 · Terminated
  RapidLab 1200 Systems, Model 1245 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
• Z-1465-06 · Apr 4, 2006 · Terminated
  RapidLab 1200 Systems, Model 1265 - Blood gases, electrolyte and blood pH test system, Bayer HealthCare LLC, Diagnostics Division
• Z-0684-06 · Jan 20, 2006 · Terminated
  Brand Name: RapidLab 1200 System, Model 1260, Part Number 05062460; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte
• Z-0685-06 · Jan 20, 2006 · Terminated
  Brand Name: RapidLab 1200 System, Model 1265, Part Number 05063769; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte
• Z-0683-06 · Jan 20, 2006 · Terminated
  Brand Name: RapidLab 1200 System, Model 1245, Part Number 05061537; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte a
• Z-0682-06 · Jan 20, 2006 · Terminated
  Brand Name: RapidLab 1200 System, Model 1240, Part Number 05060298; All RapidLab 1200 Systems with Software Versions 1.0, 1.01, or 1.02. --- Common Name: Blood gases, electrolyte a