LeadCare® II Blood Lead Analyzer KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00850355006017), received between Dec 20, 2017 and Sep 29, 2026 — classified as 137 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (29 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934879 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934869 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934868 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934867 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934864 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934862 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934859 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934855 ↗
• MalfunctionSep 24, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885464 ↗
• MalfunctionSep 24, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885460 ↗
• MalfunctionSep 24, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885323 ↗
• MalfunctionSep 22, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Customer reported presumed falsely elevated patient blood lead test results with LeadCare II.On customer reported Level 1 and Level 2 controls were outside range on (b)(6) 2026 according to test kit package insert instructions: Level 1 = "LOW" (target range = 4.9 to 10.9 ug/dL) and Level 2 = "LOW" (target range = 21.5 to 29.5 ug/dL). Customer reported controls previously were within the range on (b)(6) 2026. Customer was unable to provide previous control values.Customer reported the Blood Lead Test Kit in use as lot 2609M-01 and LeadCare II analyzer as serial number (b)(6).Customer reported they are not the end user that performs patient testing with LeadCare II. Customer stated the nurse that performs testing is unavailable. Technical Services (TS) requested a call with end user to review their method for collecting and preparing capillary blood.Customer reported testing was performed on a pediatric patient sample which resulted in a LeadCare II value of "LOW". Customer re-performed testing with the same sample which resulted in a LeadCare II value of 33.0 ug/dL. Customer performed testing a third time with the same sample which resulted in a LeadCare II value of "LOW". Customer

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858157 ↗
• MalfunctionAug 25, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437676 ↗
• MalfunctionAug 25, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437675 ↗
• MalfunctionAug 25, 2026False Positive Result

  Customer reported falsely elevated patient blood lead test results with LeadCare II.Customer reported Blood Lead Test Kit (lot 2602M, sublot unknown) Level 1 and Level 2 controls were within range upon opening according to package insert instructions. Customer reported Level 1 control values of 10.7 ug/dL, 11.7 ug/dL and 10.8 ug/dL (target range of 8.8 to 14.8 ug/dL) on (b)(6) 2026, respectively. Customer reported Level 2 control values of 29.6 ug/dL, 29.5 ug/dL and 28.8 ug/dL (target range of 27.1 to 35.9 ug/dL) on (b)(6) 2026, respectively.Customer reported an elevated LeadCare II pediatric patient blood lead test result of 3.7 ug/dL with corresponding confirmatory test result of less than 1.0 ug/dL. Customer reported HNL performed confirmation testing. Customer was unable to provide a copy of confirmation test results as results go directly into electronic patient charts.During troubleshooting Technical Services (TS) asked the customer to describe their method applied for collecting and preparing capillary blood. The customer described procedures that align with the Instructions for Use (IFU).Customer confirmed they do not use secondary micro-collection devices to collect patien

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437671 ↗
• MalfunctionAug 25, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437504 ↗
• MalfunctionAug 25, 2026False Positive Result

  Customer reported falsely elevated patient blood lead test results with LeadCare II.Customer reported Blood Lead Test Kit (lot 2602M, sublot unknown) Level 1 and Level 2 controls were within range upon opening according to package insert instructions. Customer reported Level 1 control values of 10.7 ug/dL, 11.7 ug/dL and 10.8 ug/dL (target range of 8.8 to 14.8 ug/dL) on (b)(6) 2026, respectively. Customer reported Level 2 control values of 29.6 ug/dL, 29.5 ug/dL and 28.8 ug/dL (target range of 27.1 to 35.9 ug/dL) on (b)(6) 2026, respectively.Customer reported an elevated LeadCare II pediatric patient blood lead test result of 12.8 ug/dL with corresponding confirmatory test result of 1.3 ug/dL. Customer reported HNL performed confirmation testing. Customer was unable to provide a copy of confirmation test results as results go directly into electronic patient charts.During troubleshooting Technical Services (TS) asked the customer to describe their method applied for collecting and preparing capillary blood. The customer described procedures that align with the Instructions for Use (IFU).Customer confirmed they do not use secondary micro-collection devices to collect patient samples

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437501 ↗
• MalfunctionAug 10, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196819 ↗
• MalfunctionJul 14, 2026Failure to Power Up

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813973 ↗
• MalfunctionApr 7, 2026False Positive Result

  CUSTOMER (A BIOMEDICAL ENGENEER; NOT THE END USER) REPORTED DISCREPANT BLOOD LEAD TEST RESULTS OBTAINED FROM TWO DIFFERENT LEADCARE II ANALYZERS FOR THE SAME PATIENT. QUALITY CONTROLS WERE REPORTED WITHIN RANGE; HOWEVER, SPECIFIC CONTROL VALUES AND REAGENT LOT INFORMATION WERE NOT PROVIDED. THE CUSTOMER REPORTED THAT THE ANALYZER SERIAL NUMBER: (B)(6) PRODUCED A BLOOD LEAD TEST RESULT OF 8.3 G/DL, WHILE A SECOND LEADCARE II ANALYZER PRODUCED A RESULT OF APPROXIMATELY 5.5 - 5.8 G/DL. THE SERIAL NUMBER FOR THE SECOND ANALYZER HAS NOT BEEN PROVIDED. TECHNICAL SUPPORT (TS) INQUIRED WHETHER REPEAT TESTING WAS PERFORMED USING A NEWLY COLLECTED PATIENT SAMPLE OR BY USING ORIGINAL SAMPLE LEFTOVER IN THE TREATMENT REAGENT VIAL. TS ALSO ASKED WHETHER CONFIRMATORY VENOUS BLOOD TESTING HAD BEEN CONDUCTED ON THE PATIENT. TS REQUESTED END-USER CONTACT INFORMATION. THE CUSTOMER INDICATED THEY WOULD VISIT THE END-USER SITE ON (B)(6) 2026 AND OBTAIN ADDITIONAL DETAILS. ON (B)(6) 2026, THE CUSTOMER REPORTED THAT THE TESTING SITE SUPERVISOR WAS UNSURE WHETHER THE SECOND TEST RESULT WAS OBTAINED FROM A RECOLLECTED SAMPLE OR A RERUN OF THE ORIGINAL IN THE TREATMENT REGENT VIAL. THE SAMPLE WAS REPORTEDL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24809982 ↗
• MalfunctionApr 6, 2026False Positive Result

  THE CUSTOMER REPORTED ELEVATED PATIENT TEST RESULTS WHILE USING THE LEADCARE II (LCII) SYSTEM. CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) IN RESPONSE TO IN RESPONSE TO THE MAGELLAN FIELD ACTION 1218996-01/28/2026-0001C (LEADCARE LABELING CHANGES), ASSOCIATED CRN-(B)(4). THE CUSTOMER REPORTED THAT ELEVATED PATIENT BLOOD LEAD LEVEL RESULTS WERE OBSERVED USING THE LCII SYSTEM, BUT THE ELEVATED LEVELS WERE NOT CONFIRMED WITH SUBSEQUENT CONFIRMATION TESTING. TS REQUESTED ADDITIONAL INFORMATION INCLUDING THE KIT LOT NUMBER(S) USED, A LIST OF ELEVATED LCII RESULTS, AND A LIST OF THE CONFIRMATION TEST RESULTS. THE CUSTOMER DECLINED TO PROVIDE THIS INFORMATION. TS ADVISED THE CUSTOMER TO FOLLOW CENTER FOR DISEASE CONTROL (CDC) GUIDELINES AS WELL AS THE INSTRUCTIONS INCLUDED IN THE LCII PACKAGE INSERT. THE CUSTOMER REPORTED FAMILIARITY WITH CDC GUIDELINES, AND DECLINED TO RECEIVE ADDITIONAL RESOURCES TO BE SENT VIA E-MAIL. THE CUSTOMER CONFIRMED THAT MICROTAINER TUBES WERE NOT USED FOR CAPILLARY COLLECTION; ONLY THE CAPILLARY TUBES INCLUDED IN THE KIT WERE UTILIZED. CUSTOMER REPORTED THE CONTROLS ARE IN RANGE. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE ELEVATED

  Patient problems: Insufficient Information

  MAUDE report 24796051 ↗
• MalfunctionMar 31, 2026False Positive Result

  CUSTOMER REPORTED SEEN ELEVATED BLOOD LEAD PATIENT RESULTS WITH LEADCARE II. CUSTOMER REPORTED LEADCARE II TEST RESULTS WERE NOT CONFIRMED BY LABORATORY (VENOUS) TESTING. THE NUMBER OF ELEVATED TEST RESULTS OR VALUES AND KIT LOT NUMBERS INVOLVED IN THE EVENT HAVE NOT BEEN PROVIDED OR MADE AVAILABLE TO MAGELLAN AT THE TIME OF THE REPORT. AS PART OF TROUBLESHOOTING CONDUCTED THE DESIGNATED LEADCARE II REPRESENTATIVE (RPOC), THE RPOC REPORTED CUSTOMER WAS USING PAPER TOWELS TO DRY PATIENTS' HANDS AND WAS NOT WIPING EXCESS FROM CAPILLARY TUBE BEFORE PLUNGING TO TR TUBE AS INDICATED IN IFU. RPOC PROVIDED RE-TRAINING ON (B)(6) 2026. RPOC ALSO REPORTED BATTERY CORROSION IN THE LEADCARE ANALYZER IN USE, AND NOTED BATTERIES WERE NOT ACTIVELY LEAKING, CORROSION WAS WHITE AND DRY AND CRUSTY. RPOC REMOVED BATTERIES AND INSTRUCTED THE CUSTOMER TO USE EITHER BATTERIES OR POWER CORD, NOT BOTH AT THE SAME TIME, AS INDICATED IN THE USER'S MANUAL. RPOC RAN CONTROLS WHILE ONSITE AND THEY WERE IN RANGE. AT THE TIME MAGELLAN SUBMITTED THE INITIAL MDR TO REPORT THIS EVENT (1218996-2026-00089) MAGELLAN'S POST MARKET SURVEILLANCE TEAM HAD BEEN UNABLE TO COLLECT PATIENT RESULTS INFORMATION. DURING FOLLOW U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749810 ↗
• MalfunctionMar 31, 2026False Positive Result

  CUSTOMER REPORTED SEEN ELEVATED BLOOD LEAD PATIENT RESULTS WITH LEADCARE II. CUSTOMER REPORTED LEADCARE II TEST RESULTS WERE NOT CONFIRMED BY LABORATORY (VENOUS) TESTING. THE NUMBER OF ELEVATED TEST RESULTS OR VALUES AND KIT LOT NUMBERS INVOLVED IN THE EVENT HAVE NOT BEEN PROVIDED OR MADE AVAILABLE TO MAGELLAN AT THE TIME OF THE REPORT. AS PART OF TROUBLESHOOTING CONDUCTED THE DESIGNATED LEADCARE II REPRESENTATIVE (RPOC), THE RPOC REPORTED CUSTOMER WAS USING PAPER TOWELS TO DRY PATIENTS' HANDS AND WAS NOT WIPING EXCESS FROM CAPILLARY TUBE BEFORE PLUNGING TO TR TUBE AS INDICATED IN IFU. RPOC PROVIDED RE-TRAINING ON (B)(6) 2026. RPOC ALSO REPORTED BATTERY CORROSION IN THE LEADCARE ANALYZER IN USE, AND NOTED BATTERIES WERE NOT ACTIVELY LEAKING, CORROSION WAS WHITE AND DRY AND CRUSTY. RPOC REMOVED BATTERIES AND INSTRUCTED THE CUSTOMER TO USE EITHER BATTERIES OR POWER CORD, NOT BOTH AT THE SAME TIME, AS INDICATED IN THE USER'S MANUAL. RPOC RAN CONTROLS WHILE ONSITE AND THEY WERE IN RANGE. AT THE TIME MAGELLAN SUBMITTED THE INITIAL MDR TO REPORT THIS EVENT (1218996-2026-00089) MAGELLAN'S POST MARKET SURVEILLANCE TEAM HAD BEEN UNABLE TO COLLECT PATIENT RESULTS INFORMATION. DURING FOLLOW U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749805 ↗
• MalfunctionMar 16, 2026False Positive Result

  CUSTOMER REPORTED SEEING ELEVATED BLOOD LEAD TEST RESULTS WITH LEADCARE II. MAGELLAN TECHNICAL SERVICES (TS) REQUESTED INFORMATION REGARDING THIS ISSUE, SUCH AS TEST KIT LOT NUMBER, TEST RESULT VALUES AND CORRESPONDING CONFIRMATION TEST RESULTS. HOWEVER, CUSTOMER EXPRESSED FRUSTRATION WITH THE LEADCARE II SYSTEM AND WAS UNWILLING TO PROVIDE ANY DETAILS TO TS OR MOVE FOWARD WITH TROUBLESHOOTING. CUSTOMER REQUESTED RETURN OF LEADCARE II SYSTEM. TS NOTIFIED MAGELLAN AND SALES TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613760 ↗
• MalfunctionMar 4, 2026False Positive Result

  CUSTOMER REPORTED SEEN ELEVATED BLOOD LEAD PATIENT RESULTS WITH LEADCARE II. CUSTOMER REPORTED LEADCARE II TEST RESULTS WERE NOT CONFIRMED BY LABORATORY (VENOUS) TESTING. THE NUMBER OF ELEVATED TEST RESULTS OR VALUES AND KIT LOT NUMBERS INVOLVED IN THE EVENT HAVE NOT BEEN PROVIDED OR MADE AVAILABLE TO MAGELLAN AT THE TIME OF THE REPORT. AS PART OF TROUBLESHOOTING CONDUCTED THE DESIGNATED LEADCARE II REPRESENTATIVE (RPOC), THE RPOC REPORTED CUSTOMER WAS USING PAPER TOWELS TO DRY PATIENTS' HANDS AND WAS NOT WIPING EXCESS FROM CAPILLARY TUBE BEFORE PLUNGING TO TR TUBE AS INDICATED IN IFU. RPOC PROVIDED RE-TRAINING ON (B)(6) 2026. RPOC ALSO REPORTED BATTERY CORROSION IN THE LEADCARE ANALYZER IN USE, AND NOTED BATTERIES WERE NOT ACTIVELY LEAKING, CORROSION WAS WHITE AND DRY AND CRUSTY. RPOC REMOVED BATTERIES AND INSTRUCTED THE CUSTOMER TO USE EITHER BATTERIES OR POWER CORD, NOT BOTH AT THE SAME TIME, AS INDICATED IN THE USER'S MANUAL. RPOC RAN CONTROLS WHILE ONSITE AND THEY WERE IN RANGE. AT THE TIME OF THIS REPORT ALL ATTEMPTS BY MAGELLAN'S POST MARKET SURVEILLANCE TEAM TO COLLECT ADDITIONAL INFORMATION ABOUT THIS EVENT HAVE BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510468 ↗

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-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-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-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 materi
• 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