Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 24, 2017
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collec…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Magellan Diagnostics, Inc. recalled Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 - a critical-severity action.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 was recalled by Magellan Diagnostics, Inc. in May 24, 2017. Reason: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in s…. Check the official notice for the remedy. Verify recall #Z-1926-2017 with the FDA Devices before acting.
The recall
Magellan Diagnostics, Inc. issued this critical-severity FDA Devices recall-LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in s….
- Critical
- severity level
- 1K units
- affected scope
- Class I
- classification
- May 24, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1926-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1926-2017) was formally reported on May 24, 2017, with the manufacturer initiating the action on November 29, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Magellan Diagnostics, Inc. is listed as the recalling firm, operating out of North Billerica, MA. Federal records list the affected scope as 1016.
The documented reason for this recall is: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubbe… Distribution data in the federal record shows the product reached: Nationwide Distribution. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
1016
Related Recalls
6
3 from same agency
Product description
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reason for recall
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1926-2017 |
| Date reported | May 24, 2017 |
| Date initiated | November 29, 2014 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Firm location | North Billerica, MA |
| Affected scope | 1016 |
| Distribution | Nationwide Distribution |
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-1926-2017) 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.
Frequently Asked Questions
What product was recalled? ▼
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010. Recalled by Magellan Diagnostics, Inc.. Units affected: 1016.
Why was this product recalled? ▼
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 24, 2017. Severity: Critical. Recall number: Z-1926-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1926-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 24, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.