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Magellan Diagnostics, Inc. FDA Recalls
8 recalls on file across devices, 3 of them Class I and 5 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit Class IIMar 13, 2026Customers reported observing unexpectedly elevated results w |
| LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following matClass IIMar 13, 2026Customers reported observing unexpectedly elevated results w |
| LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following matClass IIMar 13, 2026Customers reported observing unexpectedly elevated results w |
| The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. Class IIFeb 23, 2024Calibration Buttons being used in the kitting process were i |
| LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of leClass IISep 19, 2023During an internal audit a small percentage (<10%) of plasti |
| LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098Class IMay 7, 2021Magellan has received reports that control tests of either t |
| LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004Class IMay 7, 2021Magellan has received reports that control tests of either t |
| LeadCare II Blood Lead Test Kit Catalog Number 70-6762Class IMay 7, 2021Magellan has received reports that control tests of either t |