Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 7, 2018
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be us
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Magellan Diagnostics, Inc. recalled Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in f… - a moderate-severity action.
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in f… was recalled by Magellan Diagnostics, Inc. in November 7, 2018. Reason: Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will genera…. Check the official notice for the remedy. Verify recall #Z-0285-2019 with the FDA Devices before acting.
The recall
Magellan Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will genera….
- Moderate
- severity level
- Class II
- classification
- November 7, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0285-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0285-2019) was formally reported on November 7, 2018, with the manufacturer initiating the action on August 8, 2018. It is classified under Moderate severity (Class II), 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 1,465 kits.
The documented reason for this recall is: Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH. Distribution data in the federal record shows the product reached: Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa.. 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 - 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 - 40,422 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,465 kits
Related Recalls
6
0 from same agency
Product description
Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.
Reason for recall
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0285-2019 |
| Date reported | November 7, 2018 |
| Date initiated | August 8, 2018 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Firm location | North Billerica, MA |
| Affected scope | 1,465 kits |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa. |
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-0285-2019) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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 LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II 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 the LeadCare II Blood Lead Test Kit must only be used with a LeadCare II Analyzer.. Recalled by Magellan Diagnostics, Inc.. Units affected: 1,465 kits.
Why was this product recalled? ▼
Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0285-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (Nationwide) and countries of: Spain and South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0285-2019) 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 November 7, 2018. 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.