Class II U.S. Food and Drug Administration

Magellan Diagnostics, Inc. The LeadCare¿ II Blood Lead Test System relies recall: Calibration Buttons being used in the kitting process were incorrectly

Recall published 11 months ago

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.

The hazard: Lead or heavy metal content

This product was recalled over lead content above the federal limit, which is a chronic-exposure hazard rather than a one-off emergency.

What the notice says: 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.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0584-2026
Published
December 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Magellan Diagnostics, Inc.
Product type
Medical devices
Units affected
1,774 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product Name: LeadCare¿ II Blood Lead Test Kit; Catalog Number: 70-6762; Impacted Lot/Sublot Numbers: 2333M, 2333M-01, 2333M-02, 2333M-03, 2333M-04, 2333M-05, 2333M-06, 2333M-07, 2333M-08, 2333M-09, 2333M-10, 2333M-11; Device Identifier: (01)00850355006000;
UPC codes
00850355006000

Products covered by this recall

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 materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00850355006000

Model or item number

On the rating label, the box or the instruction sheet.

  • 70-6762

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 mL

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Magellan Diagnostics, Inc. — This product was recalled over lead content above the federal limit, which is a chronic-exposure hazard rather than a one-off emergency.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  3. Follow the remedy on this page — lead recalls almost always carry a full refund.
  4. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

Company contact: Magellan Diagnostics, Inc. — 101 Billerica Ave Bldg 4, North Billerica, MA, 01862-1271

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Magellan Diagnostics, Inc. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00850355006000; model number 70-6762. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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