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Use caution Medical device recall · FDA · Published January 9, 2018

Magellan LeadCare II Blood Lead Analyzer: Battery Overheating Risk

Magellan recalls LeadCare II Blood Lead Analyzers with specific part numbers due to risk of battery overheating and finger burns if removed while hot. Affected units may be used with caution after proper battery handling.

🇺🇸 FDA recall #Z-1295-2018Medical deviceMagellan ›
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Recalling firmMagellan Diagnostics, Inc.101 Billerica Ave Bldg 4 · North Billerica, MA 01862-1271
✎ GovInfoNow plain-language explainer

Magellan is recalling specific models of LeadCare II Blood Lead Analyzers because incorrect AA battery placement can cause overheating. This poses a risk of burning fingers if the batteries are removed while hot. Read more at govinfonow.com/recall/72157-magellan-leadcare-ii-blood-lead-analyzer-battery-overheating-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72157-magellan-leadcare-ii-blood-lead-analyzer-battery-overheating-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-1295-2018

Cite this page

“Magellan LeadCare II Blood Lead Analyzer: Battery Overheating Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72157-magellan-leadcare-ii-blood-lead-analyzer-battery-overheating-risk. Based on FDA recall #Z-1295-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2018%22&limit=1).

The Food and Drug Administration announced on Jan. 9, 2018, that Magellan Diagnostics, Inc. recalled LeadCare II Blood Lead Analyzers due to overheating batteries. The hazard poses a burn risk to users who remove hot batteries.

How to tell if you have it

  • Brand: Magellan
  • Product: LeadCare II Blood Lead Analyzer
  • Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R
  • Battery board versions: B and O
  • Units affected: 6,143

The hazard

The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzers may cause the batteries to overheat. This creates a chance that a user could burn their fingers if the batteries are removed while hot.

Context

GovInfoNow's records show Magellan Diagnostics, Inc. has 5 other recalls on record since 2018-08-08. Other recent recalls of similar products include Magellan LeadCare II Blood Lead Test Kits: False Positive Results Risk (2026-03-13), Magellan LeadCare II Blood Lead Test Kit: Mislabeling May Cause Inaccurate Results (2024-02-23), and Magellan LeadCare II Blood Lead Test Kit Recall: Risk of False Positive Results (2023-09-19). Other recent recalls of similar products include BD Pyxis Anesthesia Station 40: Fingerprint Scanner Overheats Risk, BD Pyxis Anesthesia Station ES REF 327 Medication Cabinet Recall: Fingerprint Scanner Overheating Risk, and BD Pyxis MedStation ES Tower 352 Medication Cabinet Recall: Fingerprint Scanner Overheats Risk (all dated 2026-04-30).

How to tell if you have this one

Check for part numbers 70-6760, 70-6529-R, 70-6760-P, or 70-6760-R on the device. The device is intended for external use only and includes battery boards versions B or O.

  • Brand
    Magellan
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution
Recall numberProduct, codes & lotsQuantity
Z-1295-2018LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.; Part Numbers: 70-6760, 70-6529-R, 70-6760-P, and 70-6760-R. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.6,143
Z-1296-2018LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.; Part Number: 82-0001. All LeadCare II and LeadCare Plus Blood Lead Analyzers with battery boards versions B and O.79
Based on the official FDA remedy

What to do — step by step

  1. Check Battery Placement

    Ensure AA batteries are correctly installed to prevent overheating.

  2. Avoid Removing Hot Batteries

    Do not remove batteries if they are hot to prevent finger burns.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Jan 9, 201812. FDA classified it Class II: Apr 3, 201823. Published in FDA’s Enforcement Report: Apr 11, 201834. FDA terminated the recall: Dec 11, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1295-2018 (January 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1295-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA