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LeadCare® II Blood Lead Test Kit
MAGELLAN DIAGNOSTICS, INC. · Model LeadCare® II · UDI-DI 00850355006000
DOF
Prescription
1
510(k) clearances
575
Adverse events
20
Recalls
3
Facilities
Description
LeadCare® II Blood Lead Test Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S |
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S |
| 2026-03-13 | Magellan Diagnostics, Inc. | Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test S |
| 2024-02-23 | Magellan Diagnostics, Inc. | Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delay |
| 2023-09-19 | Magellan Diagnostics, Inc. | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2021-05-07 | Magellan Diagnostics, Inc. | 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 lev |
| 2021-05-07 | Magellan Diagnostics, Inc. | 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 lev |
| 2021-05-07 | Magellan Diagnostics, Inc. | 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 lev |
| 2018-08-08 | Magellan Diagnostics, Inc. | 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 lo |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.