Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Magellan Diagnostics, Inc.: LeadCare II Blood Lead Test Kits Recalled for Risk of False Elevated Results

Agency Publication Date: November 3, 2023
Share:
Sign in to monitor this recall

Summary

Magellan Diagnostics is recalling 11,442 LeadCare II Blood Lead Test Kits because the plastic caps on the treatment reagent tubes may not seal properly. This defect can lead to the evaporation or leaking of hydrochloric acid (HCl), which changes the chemistry of the test and can cause falsely high lead level results. These kits are used for measuring lead in capillary blood samples and were distributed nationwide across the United States.

Risk

Defective tube caps may cause the reagent to evaporate or leak, resulting in an incorrect ratio of patient blood to testing liquid. This chemical imbalance can trigger a false positive or an inaccurately high lead reading, which could lead to unnecessary medical treatments or follow-up procedures for patients.

What You Should Do

  1. Check your LeadCare II Blood Lead Test Kit packaging for UDI-DI (01)00850355006000 to identify if your product is part of this recall.
  2. Identify if your kit belongs to any of the following affected lot numbers: 2231, 2231-10, 2303M-11, 2303M-12, 2303M-13, 2303M-15, 2305M-01, 2305M-02, 2305M-03, 2305M-04, 2305M-05, 2306M-01, 2306M-02, 2306M-03, 2306M-04, 2306M-05, 2306M-06, 2307M, 2307M-04, 2307M-05, 2307M-06, 2307M-07, 2307M-10, 2307M-11, 2308M-01, 2308M-02, 2308M-03, 2308M-07, 2309M, 2310M-01, 2310M-03, 2310M-04, 2310M-05, 2310M-06, 2310M-08, 2311M-02, 2311M-03, 2311M-05, 2311M-09, 2311M-10, 2312M, 2312M-01, 2312M-04, 2312M-05, 2312M-07, 2313M, 2313M-01, 2313M-05, 2313M-07, 2314M-06, 2314M-07, 2314M-08, 2314M-09, 2314M-12, 2314M-13, 2315M-02, 2315M-03, 2315M-04, 2315M-05, 2315M-06, 2315M-07, 2315M-08, 2315M-13, 2316M, 2316M-03, 2316M-04, 2316M-05, 2316M-06, 2316M-11, 2316M-12, 2317M, 2317M-01, 2318M, 2320M-06, or 7308M.
  3. If you have an affected kit, contact your healthcare provider or Magellan Diagnostics at 1-888-463-6332 for specific instructions on how to handle the defective tubes and to inquire about potential replacements or refunds.
  4. Healthcare providers should consider retesting patients who received high lead results using kits from the affected lots.
  5. For further questions or to report issues, contact the FDA medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: LeadCare II Blood Lead Test Kit (549,216 tests total)
Model / REF:
Z-0219-2024
UPC Codes:
00850355006000
Lot Numbers (75):
2231
2231-10
2303M-11
2303M-12
2303M-13
2303M-15
2305M-01
2305M-02
2305M-03
2305M-04
2305M-05
2306M-01
2306M-02
2306M-03
2306M-04
2306M-05
2306M-06
2307M
2307M-04
2307M-05
2307M-06
2307M-07
2307M-10
2307M-11
2308M-01
2308M-02
2308M-03
2308M-07
2309M
2310M-01
2310M-03
2310M-04
2310M-05
2310M-06
2310M-08
2311M-02
2311M-03
2311M-05
2311M-09
2311M-10
2312M
2312M-01
2312M-04
2312M-05
2312M-07
2313M
2313M-01
2313M-05
2313M-07
2314M-06

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93167
Status: Active
Manufacturer: Magellan Diagnostics, Inc.
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 11,442 LeadCare II kits (549,216 tests)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.