LeadCare® II Blood Lead Analyzer Kit, RefurbishedRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00850355006178), received between Oct 18, 2017 and Jul 13, 2018 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (13 reports).

12 other recalls cover devices cleared under the same FDA submission (K052549); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2018Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  A USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT ON (B)(6) 2018 TO REPORT THAT THE MESSAGE SCREEN OF THEIR LEADCARE BLOOD LEAD ANALYZER WAS NOT ADVANCING PROPERLY FROM TEST STEP TO TEST STEP. THERE WAS NO INDICATION AT THE TIME OF THE REPORT THAT THE ANALYZER WAS REPORTING ERRONEOUS RESULTS. THE ANALYZER WAS RETURNED TO MAGELLAN FOR EVALUATION ON (B)(6) 2018. DURING INVESTIGATIVE TESTING, MAGELLAN OBSERVED REPEATED FAILED EXTERNAL CONTROL TESTS. A REVIEW OF THE ANALYZER'S EVENT LOGS SHOWED THAT THE INSTRUMENT HAD GENERATED NUMEROUS ERROR MESSAGES OVER SEVERAL MONTHS WHILE IN USE AT THE USER FACILITY BUT THESE HAD NOT BEEN REPORTED TO MAGELLAN AS SPECIFIED IN PRODUCT LABELING. IN ADDITION, THE EVENT LOGS INDICATE THAT EXTERNAL QC WAS NOT CONSISTENTLY BEING PERFORMED ON A MONTHLY BASIS IN ACCORDANCE WITH LABEL INSTRUCTIONS. THERE HAVE BEEN NO REPORTS OF INJURIES OR ERRONEOUS RESULTS REPORTED BY THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687682 ↗
• MalfunctionJul 13, 2018Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  A USER FACILITY CALLED MAGELLAN'S PRODUCT SUPPORT ON (B)(6) 2018 TO REPORT ERROR MESSAGES ON THEIR LEADCARE II ANALYZER. THERE WAS NO INDICATION AT THE TIME OF THE REPORT THAT THE ANALYZER WAS REPORTING ERRONEOUS RESULTS. THE ANALYZER WAS RETURNED TO MAGELLAN FOR EVALUATION ON JULY 2ND 2018. DURING INVESTIGATIVE TESTING, MAGELLAN OBSERVED REPEATED FAILED EXTERNAL CONTROL TESTS. SUBSEQUENT TESTING OF BLOOD LEAD LEVEL REFERENCE STANDARDS WERE ALL WITHIN TARGET RANGES. A REVIEW OF THE ANALYZER'S EVENT LOGS SHOWED THAT THE INSTRUMENT HAD GENERATED NUMEROUS ERROR MESSAGES OVER SEVERAL MONTHS WHILE IN USE AT THE USER FACILITY BUT THESE HAD NOT BEEN REPORTED TO MAGELLAN AS SPECIFIED IN PRODUCT LABELING. IN ADDITION, THE EVENT LOGS INDICATE THAT EXTERNAL QC WAS NOT CONSISTENTLY BEING PERFORMED ON A MONTHLY BASIS IN ACCORDANCE WITH LABEL INSTRUCTIONS. THERE HAVE BEEN NO REPORTS OF INJURIES OR ERRONEOUS RESULTS REPORTED BY THE USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687680 ↗
• MalfunctionJun 28, 2018Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER CALLED MAGELLAN PRODUCT SUPPORT EXPLAINING THEY WERE UNABLE TO GET THE QUALITY CONTROLS IN THE PROPER RANGE. TEST KIT AND ANALYZER WERE RETURNED TO MAGELLAN DIAGNOSTICS. CUSTOMER COMPLAINT OF CONTROLS OUT OF RANGE WAS CONFIRMED TO BE RELATED TO THE ANALYZER. REVIEW OF ANALYZER EVENT LOGS ALSO SHOWED THE CUSTOMER WAS NOT CONSISTENTLY RUNNING PERIODIC QC ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS AND THAT MANY ERROR MESSAGES HAD OCCURED THAT WERE NOT REPORTED TO MAGELLAN. NO REPORTED INJURIES OCCURRED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7648039 ↗
• MalfunctionJun 27, 2018Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  CUSTOMER CALLED MAGELLAN PRODUCT SUPPORT TO REPORT A POWER ON SELF-TEST ERROR. REBOOT OF THE ANALYZER CLEARED THIS ERROR. DURING CALL WITH PRODUCT SUPPORT THE CUSTOMER NOTED THAT THE A/C ADAPTER HEATED UP WHEN THE ANALYZER WAS POWERED ON. THE CUSTOMER'S ANALYZER AND A/C ADAPTER WERE RETURNED TO MAGELLAN FOR FURTHER INVESTIGATION. DURING IN-HOUSE INVESTIGATION OF THE CUSTOMER'S RETURNED A/C ADAPTER IT WAS NOTED THAT IT HEATED UP WHEN POWERING ON THE ANALYZER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643371 ↗
• MalfunctionMar 16, 2018Electrical Shorting; Noise, Audible; Electrical Shorting; Noise, Audible

  INSTRUMENT LOSES POWER. CRACKLING SOUND HEARD WHEN A/C ADAPTER IS WIGGLED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7346355 ↗
• MalfunctionMar 9, 2018Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER REPORTED BOTH USED SENSOR AND TEST FAILED ERROR MESSAGES WHEN ATTEMPTING TO RUN THE ASSAY. CORROSION NOTED ON THE SENSOR PINS. MAGELLAN TESTING OF RETURNED ANALYZER SHOWED QC OUT OF RANGE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7328458 ↗
• MalfunctionDec 22, 2017Bent; Failure to Sense; Device Sensing Problem; Bent; Failure to Sense; Device Sensing Problem

  ANALYZER WOULD NOT RUN WHEN SAMPLE WAS APPLIED TO THE SENSOR. BASED ON TROUBLESHOOTING OVER THE PHONE, ANALYZER ERROR CODES WERE BEING GENERATED WHILE ATTEMPTING TO RUN THE INSTRUMENT. THE ANALYZER DOES NOT GENERATE RESULTS WHEN THESE TYPES OF ERROR CODES OCCUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142623 ↗
• MalfunctionDec 22, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER REPORTED DIFFICULTY GETTING BOTH LEVELS OF QC REAGENTS IN RANGE OF THEIR EXPECTED VALUES. QC TESTING LAST IN RANGE 3 WEEKS PRIOR TO COMPLAINT. QC TESTING WITH MANUFACTURER'S BLOOD LEAD CONTROLS WAS PERFORMING AS EXPECTED IN THAT IT IDENTIFIED AN ISSUE WITH THE LEADCARE SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142604 ↗
• MalfunctionDec 22, 2017Bent; Failure to Sense; Device Sensing Problem; Bent; Failure to Sense; Device Sensing Problem

  THE ANALYZER DISPLAY WAS CHANGING AT INAPPROPRIATE INTERVALS. THIS TYPE OF ERROR GENERATES NO RESULTS WHEN IT OCCURS. CUSTOMER REPORTED APPEARANCE OF CORROSION OF THE PINS, AND ONE BENT PIN. TESTING OF THE CUSTOMER'S ANALYZER AT MAGELLAN SHOWED ALL QC RESULTS OUT OF RANGE LOW. CUSTOMER WAS NOT RUNNING PERIODIC QC ACCORDING TO MANUFACTURER'S INSTRUCTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142580 ↗
• MalfunctionDec 22, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER STARTED EXPERIENCING "SYSTEM FAILED" MESSAGES DURING STARTUP OF THE ANALYZER. IN THESE CASES, THE ANALYZER WILL NOT GENERATE RESULTS. THE ANALYZER ERROR LOG SHOWS THAT ANALYZER ERRORS WERE GENERATED IN LARGE NUMBERS PRIOR TO THE COMPLAINT CALL. ANALYZER WAS PERFORMING AS EXPECTED IN GENERATING THOSE ERROR MESSAGES HOWEVER CUSTOMER CONTINUED TO RUN THE ANALYZER. REVIEW OF ANALYZER EVENT LOGS ALSO SHOWED THE CUSTOMER WAS NOT CONSISTENTLY RUNNING PERIODIC QC ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. WHEN CUSTOMER DID RUN CONTROLS THEY WERE OUT OF RANGE. NO REPORTED INJURIES OCCURRED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142096 ↗
• MalfunctionDec 22, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER CALLED WITH COMPLAINT OF USED SENSOR ERRORS. WHEN THE ERROR OCCURS NO RESULTS ARE GENERATED BY THE INSTRUMENT. ANALYZER WAS PERFORMING AS EXPECTED BY GENERATING THOSE ERRORS. THE CUSTOMER WAS NOT RUNNING QC ACCORDING TO MANUFACTURER'S INSTRUCTIONS. CUSTOMER CONTINUE TO TEST PATIENT SAMPLES IN THE PRESENCE OF RECURRING ERROR MESSAGES. NO REPORTED HARM OR INJURIES OCCURRED AS A RESULT OF THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7142018 ↗
• MalfunctionDec 22, 2017Battery Problem; Noise, Audible; Battery Problem; Noise, Audible

  CUSTOMER ATTEMPTED TO POWER THE ANALYZER ON WITH BATTERIES INSTALLED, HEARD A SIZZLING NOISE FROM THE BATTERY COMPARTMENT, AND VERIFIED THAT THE BATTERIES WERE LEAKING INTO THE COMPARTMENT. NO HARM OR INJURIES TO THE USER WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141964 ↗
• MalfunctionDec 22, 2017Electrical Shorting; Noise, Audible; Electrical Shorting; Noise, Audible

  INSTRUMENT REPORTED TO GENERATE 102 ERROR CODES. IN ADDITION, THE AC ADAPTER FOR ANALYZER BECAME EXTREMELY HOT. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7141900 ↗
• MalfunctionDec 20, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER REPORTED USED SENSOR ERRORS WHEN A NEW SENSOR IS INSERTED INTO ANALYZER. CUSTOMER WAS RUNNING QC OCCASIONALLY, BUT LAST IN-RANGE QC TEST WAS SEVEN WEEKS PRIOR TO COMPLAINT. MAGELLAN RECOMMENDS QC TESTS BE PERFORMED MONTHLY. QC TESTING PERFORMED AT MAGELLAN ON CUSTOMER'S RETURNED ANALYZER REPLICATED OUT OF RANGE TEST RESULTS. ANALYZER SENSOR PINS WERE REPORTED TO EXHIBIT SIGNS OF CORROSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135825 ↗
• MalfunctionDec 20, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER WAS ENCOUNTERING NUMEROUS ERROR CODES 102 ON THE ANALYZER. THE ANALYZER DOES NOT GENERATE RESULTS WHEN THESE TYPES OF ERROR CODES OCCUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135793 ↗
• MalfunctionDec 20, 2017Failure to Power Up; Smoking; Failure to Power Up; Smoking

  ALL LABORATORY EQUIPMENT HAD BEEN UNPLUGGED DURING HURRICANE (B)(4). THE A/C ADAPTER WAS LEFT PLUGGED INTO THE SURGE PROTECTOR, BUT NOT INTO THE INSTRUMENT. ON REOPENING OF LABORATORY, CUSTOMER WAS PLUGGING ALL EQUIPMENT BACK INTO POWER SUPPLIES. ON PLUGGING THE A/C ADAPTER BACK INTO THE ANALYZER, THE ANALYZER BEGAN SMOKING. NO INJURY OR OTHER ADVERSE EVENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7135786 ↗
• MalfunctionDec 20, 2017Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  CUSTOMER COMPLAINED THAT THEIR LEACCARE II WOULD NOT RUN WHEN SAMPLE WAS APPLIED TO THE SENSOR. BASED ON TROUBLESHOOTING OVER THE PHONE, ANALYZER ERROR CODES WERE BEING GENERATED WHILE ATTEMPTING TO RUN THE INSTRUMENT INDICATING A PERFORMANCE ISSUE WITH THE ANALYZER. THE ANALYZER DOES NOT GENERATE RESULTS WHEN THESE TYPES OF ERROR CODES OCCUR. CUSTOMER INSPECTION OF THE ANALYZER AT THE REQUEST OF MAGELLAN INDICATED CORROSION WAS VISIBLE ON THE ANALYZER PINS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135644 ↗
• MalfunctionDec 20, 2017Bent; Device Sensing Problem; Bent; Device Sensing Problem

  CUSTOMER WAS GETTING ANALYZER ERRORS UPON APPLICATION OF SAMPLE PREP TO SENSOR. IN ADDITION, DURING TROUBLESHOOTING CUSTOMER WAS GETTING QC OUT OF RANGE LOW. ON EXAMINATION IT APPEARED THAT ONE ANALYZER PIN WAS BENT. CUSTOMER MAY NOT HAVE BEEN REMOVING SPENT SENSOR IMMEDIATELY AFTER TESTING. CUSTOMER WAS NOT ALWAYS APPLYING SAMPLE CORRECTLY. ALL QC RESULTS WERE OUT OF RANGE LOW UPON TESTING BY MAGELLAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135634 ↗
• MalfunctionDec 20, 2017Leak/Splash; Battery Problem; Leak/Splash; Battery Problem

  ON POWER UP IN BATTERY MODE, A BATTERY RUPTURED AND LEAKED BATTERY ACID. NO HARM OR INJURY TO USER WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7135598 ↗
• MalfunctionDec 20, 2017Electrical Shorting; Noise, Audible; Electrical Shorting; Noise, Audible

  SIZZLING, CRACKLING, ELECTRICAL SOUNDS WERE HEARD WHEN THE ANALYZER WAS REBOOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7135539 ↗
• MalfunctionOct 18, 2017Battery Problem; Battery Problem

  THE INSTRUMENT'S BATTERIES BURNED USER AFTER THE USER IMPROPERLY TOOK THE ANALYZER APART TO CHANGE THE BATTERIES. NO MEDICAL INTERVENTION WAS NECESSARY OR TAKEN. LATE FILING IS PART OF (B)(6)'S RESPONSE TO FDA'S 483 ISSUED JUNE 29, 2017.

  Patient problems: Burn, Thermal

  MAUDE report 6958207 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052549. One submission often covers many models, so check the product and lot details in each record.

• Z-1895-2026 · Mar 13, 2026 · Open, Classified
  LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Tre
• Z-1893-2026 · Mar 13, 2026 · Open, Classified
  (1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (
• Z-0584-2026 · Feb 23, 2024 · Open, Classified
  The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following mate
• Z-0219-2024 · Sep 19, 2023 · Open, Classified
  LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
• Z-1597-2022 · May 25, 2022 · Open, Classified
  MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General Chemistry Blood Lead Test Whole Blood Sample 48 Tests Model Number: 70-6762
• Z-1952-2021 · May 7, 2021 · Terminated
  LeadCare II Blood Lead Test Kit Catalog Number 70-6762
• Z-0285-2019 · Aug 8, 2018 · Terminated
  Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Bl
• Z-1295-2018 · Jan 9, 2018 · Terminated
  LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
• Z-2226-2017 · May 23, 2017 · Terminated
  Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quan
• Z-3035-2017 · Jan 20, 2016 · Terminated
  LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagen
• Z-0043-2008 · Sep 20, 2007 · Terminated
  ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
• Z-0042-2008 · Sep 20, 2007 · Terminated
  ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762