LeadCare® II Blood Lead Test KitRecalls & reported problems

Summary

The FDA's MAUDE database contains 353 adverse event reports that list this exact device (DI 00850355006000), received between Apr 6, 2015 and Sep 30, 2026 — classified as 352 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (229 reports).

4 FDA recall records name this device's identifier, 4 still open.

8 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.

Recalls naming this device

1. Mar 13, 2026Open, 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-1893-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 23, 2024Open, Classified

   Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

   Z-0584-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

3. Sep 19, 2023Open, Classified

   During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

   Z-0219-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1597-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 353 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949692 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949681 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949680 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949679 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949674 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949672 ↗
• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949670 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934900 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934895 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934892 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934888 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934885 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934881 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934876 ↗
• MalfunctionSep 29, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934860 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917525 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917520 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917516 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917390 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917387 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917386 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917385 ↗
• MalfunctionSep 28, 2026False Positive Result

  Customer reported a falsely elevated patient blood lead test result with LeadCare II.Customer reported an elevated LeadCare II pediatric patient blood lead test result of 39.1 ug/dL. Customer reported a secondary EDTA microtainer device (SARSTEDT) was used for blood collection. Customer reported a second sample was collected from the patient on the same day using a capillary tube from the LeadCare II Blood Lead Test Kit. Customer reported the second sample resulted in a LeadCare II test value of "LOW" (less than 3.3 ug/dL). Customer reported the corresponding confirmation test result was less than 1.0 ug/dL. Technical Services (TS) instructed the customer to only use the capillary tubes for blood collection provided in the LeadCare II Blood Lead Test Kit.During troubleshooting TS asked the customer to describe their method for collecting and preparing capillary blood. Customer reported they are not familiar with the procedure.TS instructed the customer to follow the CDC guidelines for capillary blood lead collection. TS provided the CDC Capillary Collection video to the customer.Customer reported Level 1 and Level 2 controls were within range according to the package insert instruc

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917384 ↗
• MalfunctionSep 28, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917381 ↗
• MalfunctionSep 28, 2026False Positive Result

  Customer reported suspected falsely elevated patient blood lead test results with LeadCare II.On (b)(6)2026 the customer reported elevated patient blood lead test results and used sensor error messages with their LeadCare II Blood Lead Test Kit.Customer stated they are a manager and was unable to provide additional information at the time of contact.On (b)(6)2026 customer reported an elevated LeadCare II pediatric patient blood lead test result of 4.0 ug/dL. Customer stated the patient was not sent for venous confirmation testing.During troubleshooting Technical Services (TS) asked the customer to describe their method for collecting and preparing capillary blood. The customer stated they did not have time to describe the testing procedure in depth. TS briefly reviewed the CDC guidelines for capillary blood lead collection with the customer. TS provided the customer with the CDC Capillary Collection video.TS replaced the customer's LeadCare II Blood Lead Test Kit and analyzer due to the used sensor report.On (b)(6)2026 customer stated they would like a follow-up from TS in one month.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917379 ↗

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-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