Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SD BiosensorLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Magellan Diagnostics with 17 device recalls and 2 510(k) clearances. The most recent is a device recall dated Sep 4, 2026: LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 4, 2026 | LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.Class III · In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of J | Device recalls |
| Mar 13, 2026 | LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors Class II · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to co | Device recalls |
| Mar 13, 2026 | (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number(s)Class II · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to co | Device recalls |
| Mar 13, 2026 | LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors Class II · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to co | Device recalls |
| Feb 23, 2024 | The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II TeClass II · Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mi | Device recalls |
| Sep 19, 2023 | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary wholClass II · During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found | Device recalls |
| May 7, 2021 | LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098Class I · Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low resul | Device recalls |
| May 7, 2021 | LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004Class I · Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low resul | Device recalls |
| Jul 7, 2015 | LeadCare Plus Blood Lead Testing SystemK142705 · DOF | 510(k) clearances |
| Aug 20, 2013 | LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEMK123563 · DOF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
