Lower risk Medical device recall · FDA · Published September 4, 2026

LeadCare II Blood Lead Test Kit: Wrong Expiration Date Causes Delayed Results

Magellan Diagnostics recalls 321 LeadCare II Blood Lead Test Kits with incorrect expiration date (July 22, 2026) that may cause delayed test results. Affected kits sold nationwide in CA, IN, PA, TX, NE, IL, MA, MO, KY.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0162-2027Medical device Magellan Diagnostics ›

Lower-risk recall

In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.

✎ GovInfoNow plain-language explainer

Magellan Diagnostics is recalling 321 LeadCare II Blood Lead Test Kits with a wrong expiration date. Using these kits may cause delayed test results because the system displays an error message and prevents running tests. Read more at govinfonow.com/recall/1764696-magellan-diagnostics-inc-recalls-leadcare-ii-blood-lead-test-kit.

Source Summary by GovInfoNow · govinfonow.com/recall/1764696-magellan-diagnostics-inc-recalls-leadcare-ii-blood-lead-test-kit · Published October 27, 2026 · Updated October 27, 2026 · FDA enforcement record: FDA #Z-0162-2027

Cite this page

“LeadCare II Blood Lead Test Kit: Wrong Expiration Date Causes Delayed Results.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764696-magellan-diagnostics-inc-recalls-leadcare-ii-blood-lead-test-kit. Based on FDA recall #Z-0162-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0162-2027%22&limit=1).

The FDA announced on September 4, 2026, that Magellan Diagnostics is recalling the LeadCare II Blood Lead Test Kit because incorrect expiration dates may cause delayed results. The agency issued recall number Z-0162-2027 for the Class III device.

How to tell if you have it

Brand: Magellan Diagnostics
Product: LeadCare II Blood Lead Test Kit
Model/Catalog Number: 70-6762
Lot Number: 2530M-01
UD-DI: 00850355006000

The hazard

In kit sub-lot 2530M-01, the outer labeling may show an expiration date of July 22, 2026, while the correct date is July 13, 2026. If used, the system displays an error message and prevents the operator from running the test, resulting in delayed results.

Context

GovInfoNow's records show Magellan Diagnostics has issued six other recalls since January 9, 2018. Other recent recalls of similar products include LeadCare Ultra Blood Lead Test Kit (March 13, 2026), LeadCare II Blood Lead Test Kit (February 23, 2024), and LeadCare II Blood Lead Test Kit Recall (September 19, 2023). Other recent recalls of similar products include Inspire Stimulation Lead Recall (May 11, 2026), Inspire Respiratory Sensing Lead Model 4340 (May 11, 2026), and Urinary Clean Catch Kit Recalled Due to Incorrect Expiration Date (July 9, 2026).

How to tell if you have this one

Check for the model number 70-6762 and lot number 2530M-01 on the kit's outer label. The kit was sold nationwide in CA, IN, PA, TX, NE, IL, MA, MO, KY.

Brand
Magellan Diagnostics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Expiration Date
Verify the expiration date on the outer label matches July 13, 2026. If it shows July 22, 2026, this kit is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

FDA distribution: “US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Illinois, Indiana, Kentucky, Massachusetts, Missouri, Nebraska, Pennsylvania, Texas.

Recall timeline

FDA published this recall 47 days after the firm started it.

Sep 4, 2026Firm started the recall
Oct 15, 2026FDA classified it Class III
Oct 21, 2026Published in FDA’s Enforcement Report
Oct 27, 2026Added to GovInfoNow

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

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Keep exploring

More Magellan Diagnostics recalls

Link to this recall

<a href="https://govinfonow.com/recall/1764696-magellan-diagnostics-inc-recalls-leadcare-ii-blood-lead-test-kit">LeadCare II Blood Lead Test Kit: Wrong Expiration Date Causes Delayed Results (GovInfoNow)</a>

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-0162-2027 (September 4, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0162-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 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.