FDA Devices recall · Reported July 7, 2021
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
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 le…
Magellan Diagnostics, Inc. recalled LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 - a critical-severity action.
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 was recalled by Magellan Diagnostics, Inc. in July 7, 2021. Reason: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated …. Check the official notice for the remedy. Verify recall #Z-1953-2021 with the FDA Devices before acting.
The recall
Magellan Diagnostics, Inc. issued this critical-severity FDA Devices recall-Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated ….
- Critical
- severity level
- Class I
- classification
- July 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1953-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Reason for 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1953-2021 |
| Date reported | July 7, 2021 |
| Date initiated | May 7, 2021 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Firm location | North Billerica, MA |
| Affected scope | 320 kits (96 tests/kit=30,720 tests) |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1953-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026