RAPIDLab® 1200 Series 1265 10321852Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00630414515571), received between Jan 23, 2018 and Apr 15, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (7 reports).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH TOTAL HEMOGLOBIN (THB) RESULT COMPARED TO RETESTING OF THE SAME SAMPLE ON ANOTHER RL1265 INSTRUMENT AND A DIFFERENT SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19110893 ↗
• MalfunctionAug 27, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED SEVERAL DISCREPANT THB RESULTS ON THEIR RL1265 INSTRUMENT COMPARED TO RETESTING OF DIFFERENT SAMPLES ON A NON-SIEMENS HEMATOLOGY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10461496 ↗
• MalfunctionMar 11, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT LOW LACTATE RESULTS FROM ONE PATIENT ON THE RL 1265 WHEN COMPARED TO THE LACTATE RESULTS ON THE RP 500. THE CUSTOMER STATED THE PATIENT WAS IN CRITICAL CONDITION AND ADMITTED TO THE ICU FOR SEVERAL DAYS PRIOR TO THE EVENT. THE PATIENT HAD SEPSIS WHICH RAPIDLY PROGRESSED. THE CUSTOMER INDICATED THE PATIENT IS DECEASED. SAFETY DATA INFORMATION FROM THE COMPLAINT STATES THAT THE CUSTOMER IN NOT ALLEGING HARM TO THE PATIENT DUE TO THE USE OF THE DEVICE.

  Patient problems: Death

  MAUDE report 9817843 ↗
• MalfunctionFeb 19, 2020Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS ON THE RL 1265. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729533 ↗
• MalfunctionDec 12, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN AND HEMATOCRIT RESULTS ON THE RL 1265 INSTRUMENT WHEN COMPARED TO A NON-SIEMENS HEMATOLOGY SYSTEM. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9460762 ↗
• MalfunctionOct 17, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT POTASSIUM RESULTS ON THE RL 1265. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: Abnormal Blood Gases

  MAUDE report 9205301 ↗
• MalfunctionMar 11, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED DISCREPANT TOTAL HEMOGLOBIN RESULTS FROM TWO RL 1265 INSTRUMENTS AND A NON-SIEMENS HEMATOLOGY ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408647 ↗
• MalfunctionJan 16, 2019Non Reproducible Results; Non Reproducible Results

  THE CUSTOMER REPORTED THAT THE CO-OX VALUES FOR ONE PATIENT COULD NOT BE DETERMINED WHEN RUN SEVERAL TIMES ON THE RL 1265 BECAUSE THE CO-OX SYSTEM DID NOT DETECT THE SAMPLE WITHIN THE MAXIMUM AMOUNT OF TIME ALLOWED. IN EACH INSTANCE A "D71 NO SAMPLE DETECTED AT FD3" ERROR MESSAGE WAS RECEIVED. THE CUSTOMER STATED THAT THIS EVENT CAUSED A DELAY IN MEASUREMENT BUT THE PATIENT WAS NOT HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253523 ↗
• MalfunctionJul 5, 2018Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCORDANT TOTAL HEMOGLOBIN RESULTS BETWEEN TWO RL 1265S. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7665018 ↗
• MalfunctionApr 24, 2018Incorrect Or Inadequate Test Results

  THE CUSTOMER REPORTED DISCREPANT GLUCOSE VALUES ON TWO RL 1265 INSTRUMENTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7453876 ↗
• MalfunctionMar 22, 2018Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED DISCREPANT IONIZED CALCIUM RESULTS ON TWO PATIENTS BETWEEN TWO RL 1265 INSTRUMENTS. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7362955 ↗
• MalfunctionJan 23, 2018Fluid/Blood Leak

  THE CUSTOMER REPORTED FLUID LEAKAGE BELOW THE REAGENT CARTRIDGE OF THE RL 1265 BLOOD GAS ANALYZER WHICH WAS A COMBINATION OF REAGENTS AND BLOOD. THE CUSTOMER STATED THE OPERATOR WAS WEARING PROTECTIVE CLOTHING AND GLOVES AND THERE WAS NO SKIN EXPOSURE. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 7213431 ↗

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-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-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-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-2800-2016 · Aug 11, 2016 · Terminated
  Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
• Z-2801-2016 · Aug 11, 2016 · Terminated
  RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
• 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-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-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-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-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-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
• 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-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-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