LeadCare® Ultra Blood Lead Test KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00850355006024), received between Dec 22, 2017 and Nov 22, 2019 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (18 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 13, 2026Class IIOpen, Classified

   Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.

   Z-1895-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SAMPLES TESTED IMMEDIATELY ON LEADCARE ULTRA AFTER PREPARATION IN TREATMENT REAGENT GIVE LOWER RESULTS THAN WHEN THE BLOOD/TREATMENT REAGENT MIXTURE WAS HELD FOR A PERIOD OF TIME BEFORE TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365044 ↗
• MalfunctionNov 22, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SAMPLES TESTED IMMEDIATELY ON LEADCARE ULTRA AFTER PREPARATION IN TREATMENT REAGENT GIVE LOWER RESULTS THAN WHEN THE BLOOD/TREATMENT REAGENT MIXTURE WAS HELD FOR A PERIOD OF TIME BEFORE TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365035 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00040 ADDENDUM. SAMPLES TESTED WITH LEADCARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356628 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00040 ADDENDUM: SAMPLES TESTED WITH LEADCARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356625 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM. SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356624 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM: SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356622 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00035 ADDENDUM. CUSTOMER REPORTED SAMPLES TESTED IMMEDIATELY AFTER ADDITION TO TREATMENT REAGENT PRODUCE LOWER BLOOD LEAD VALUES THAN WHEN THEY ARE ALLOWED TO SIT FOR 1 HOUR, 24 HOURS, OR 72 HOURS IN THE TREATMENT REAGENT BEFORE TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356620 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00040 ADDENDUM: SAMPLES TESTED WITH LEADCARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356617 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM: SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356614 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00040 ADDENDUM: SAMPLES TESTED WITH LEADCARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356613 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM: SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED).BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356612 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  1218996-2017-00041 ADDENDUM BLOOD/TREATMENT REAGENT MIXTURES TESTED WITH LEADCARE ULTRA PRODUCE RESULTS AT TIME T=0 THAT ARE LOWER THAN WHEN THE MIXTURE IS HELD AND THEN TESTED AT T=24, AND T=48.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356610 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00040 ADDENDUM: SAMPLES TESTED WITH LEADCARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356609 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM: SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356607 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM: SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED). BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356605 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR#: 1218996-2017-00040 ADDENDUM. SAMPLES TESTED WITH LEAD CARE ULTRA PRODUCED RESULTS THAT WERE LOW WHEN COMPARED TO THE REFERENCE METHOD ICP/MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356602 ↗
• MalfunctionNov 21, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  128996-2017-00039 ADDENDUM. SAMPLES INITIALLY TESTED WITH LEADCARE ULTRA PRODUCED LOW TEST RESULTS WHEN COMPARED TO THE REFERENCE METHOD (UNSPECIFIED).BLOOD/TREATMENT REAGENT MIXTURES WERE SUBSEQUENTLY RETESTED FOLLOWING AN HOUR LONG INCUBATION. RESULTS FOLLOWING THE ONE-HOUR HOLD TIME WERE CLOSER TO THE REFERENCE VALUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9356598 ↗
• MalfunctionOct 21, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM. CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9213357 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM. CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159270 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM: CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159268 ↗
• MalfunctionOct 4, 2019False Negative Result; False Negative Result

  MDR 1218996-2017-00038 ADDENDUM: CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159267 ↗
• MalfunctionOct 4, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MDR 1218996-2017-00036 ADDENDUM: SAMPLES TESTED IMMEDIATELY AFTER PREPARATION IN TREATMENT REAGENT PRODUCED LOWER BLOOD LEAD VALUES THAN WHEN THEY WERE HELD IN TREATMENT REAGENT FOR A PERIOD OF TIME BEFORE TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159265 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM: CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159264 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM: CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159263 ↗
• MalfunctionOct 4, 2019Low Test Results; Low Test Results

  MDR 1218996-2017-00038 ADDENDUM: CUSTOMER REPORTED THAT RESULTS OF SAMPLES TESTED BY LEADCARE ULTRA WERE LOW COMPARED TO AN OLDER MODEL OF THE DEVICE AND ICP-MS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9159262 ↗