Lower risk Medical device recall · FDA · Published May 7, 2021

Magellan LeadCare Ultra Blood Lead Test Kit Recall: Underestimation Risk

Magellan recalls LeadCare Ultra Blood Lead Test Kit (Catalog 70-8098) due to potential underestimation of blood lead levels in patient samples. Affected units sold from 2011 to 2022.

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

🇺🇸 FDA recall #Z-1954-2021Medical device Magellan ›

Lower-risk recall

Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

Take action

Contact the company

Recalling firmMagellan Diagnostics, Inc.101 Billerica Ave Bldg 4 · North Billerica, MA 01862-1271

✎ GovInfoNow plain-language explainer

Magellan is recalling its LeadCare Ultra Blood Lead Test Kit (Catalog 70-8098) because control tests may give low results, leading to inaccurate blood lead level measurements. This could cause health risks if patients are misinformed about lead exposure. Read more at govinfonow.com/recall/62588-magellan-leadcare-ultra-blood-lead-test-kit-recall-underestimation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62588-magellan-leadcare-ultra-blood-lead-test-kit-recall-underestimation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1954-2021

Cite this page

“Magellan LeadCare Ultra Blood Lead Test Kit Recall: Underestimation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62588-magellan-leadcare-ultra-blood-lead-test-kit-recall-underestimation-risk. Based on FDA recall #Z-1954-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1954-2021%22&limit=1).

The FDA announced on May 7, 2021, that Magellan Diagnostics, Inc. is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098). The hazard involves control tests generating low results, which may cause underestimation of blood lead levels in patient samples.

How to tell if you have it

Magellan LeadCare Ultra Blood Lead Test Kit
Catalog Number 70-8098
Lot Numbers: 2011MU - 25MAR22, 2104MU - 25AUG22, 2108MU - 31MAR22

The hazard

Magellan received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.

Context

GovInfoNow's records show Magellan Diagnostics, Inc. has 5 other recalls on record since 2018-01-09. Other recent recalls of similar products include Cepheid Xpert BCR-ABL Ultra Test Kits (2025-10-30), Beckman Coulter DxH Diluent Recall (2025-11-10), and Siemens Atellica CH Urine Albumin Recall (2026-07-06).

How to tell if you have this one

Check for Catalog Number 70-8098 on the kit. Units were sold with Lot Numbers 2011MU to 25MAR22, and later expansions 2104MU to 25AUG22 and 2108MU to 31MAR22.

Brand
Magellan
Category
Medical device

FDA recall event · 3 products

All 3 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 I
Status
Terminated
Distribution
Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.

Recall number	Product, codes & lots	Quantity
Z-1952-2021	LeadCare II Blood Lead Test Kit Catalog Number 70-6762; Lot Numbers/Expiration Date: 2013M - 22APR22; 2014M - 29APR22; 2015M - 12MAY22; 2016M - 19MAY22; 2017M - 10JUN22; 1st expansion 6/21/2021: 2101M - 28JUL22; 2103M - 18AUG22; 2105M - 11SEP22; 2106M - 21JAN22; 2107M - 30SEP22; 2nd expansion 8/30/2021; 2012M Sublots: -08, -09, -10, -11, -12, -13, -14 - 08APR22; 2018M - 06JUN22; 2102M - 30SEP21; 2109M - 15OCT22; 2110M - 29OCT22; 2111M - 31MAY22; 2112M - 13NOV22; 2113M - 30JUN22; 2114M - 17DEC22; 2115M - 29DEC22; 7114M - 17DEC22.	387,281 kits (48 tests/kit=1,757,040 tests)
Z-1953-2021	LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004; Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.	320 kits (96 tests/kit=30,720 tests)
Z-1954-2021	LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098; Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.	441 kits (192 tests/kit = 84,672 tests)

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Look for Catalog Number 70-8098 on the test kit packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

May 7, 2021Firm started the recall
Jul 1, 2021FDA classified it Class I
Jul 7, 2021Published in FDA’s Enforcement Report
Oct 24, 2023FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How can I tell if my kit is affected?

Check for Catalog Number 70-8098 and Lot Numbers 2011MU-25MAR22, 2104MU-25AUG22, or 2108MU-31MAR22.

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Link to this recall

<a href="https://govinfonow.com/recall/62588-magellan-leadcare-ultra-blood-lead-test-kit-recall-underestimation-risk">Magellan LeadCare Ultra Blood Lead Test Kit Recall: Underestimation Risk (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-1954-2021 (May 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1954-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.