Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 14, 2017
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Magellan Diagnostics, Inc. recalled Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The L… - a critical-severity action.
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The L… was recalled by Magellan Diagnostics, Inc. in June 14, 2017. Reason: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare s…. Check the official notice for the remedy. Verify recall #Z-2226-2017 with the FDA Devices before acting.
The recall
Magellan Diagnostics, Inc. issued this critical-severity FDA Devices recall-Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare s….
- Critical
- severity level
- Class I
- classification
- June 14, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2226-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2226-2017) was formally reported on June 14, 2017, with the manufacturer initiating the action on May 23, 2017. 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 6018 kits (total)= 5818 (US)and 200 (OUS).
The documented reason for this recall is: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NE…. 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
6018 kits (total)= 5818 (US)and 200 (OUS)
Related Recalls
6
3 from same agency
Product description
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Reason for recall
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2226-2017 |
| Date reported | June 14, 2017 |
| Date initiated | May 23, 2017 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Firm location | North Billerica, MA |
| Affected scope | 6018 kits (total)= 5818 (US)and 200 (OUS) |
| Distribution | Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALA… |
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-2226-2017) 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 and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.. Recalled by Magellan Diagnostics, Inc.. Units affected: 6018 kits (total)= 5818 (US)and 200 (OUS).
Why was this product recalled? ▼
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Critical. Recall number: Z-2226-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2226-2017) 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 June 14, 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.