Magellan Diagnostics, Inc. recalls
Every recall we track for Magellan Diagnostics, Inc. — 12 in all, from 2018–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
12 recalls since 2017.
All FDA recall records for Magellan Diagnostics, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 2 | 1 | 0 | 3 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 4 | 0 | 4 |
What to do if you have a recalled Magellan Diagnostics, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Magellan Diagnostics, Inc. recalls
7 shown- Lower riskMedical device
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Magellan Diagnostics recalls 321 LeadCare II Blood Lead Test Kits with incorrect expiration date (July 22, 2026) that may cause delayed test results. Affected kits sold nationwide in CA, IN, PA, TX, NE, IL, MA, MO, KY.
Magellan DiagnosticsSep 4, 2026 - Lower riskMedical device
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following
Magellan recalls LeadCare Plus Blood Lead Test Kit (Catalog 82-0004) due to false positive lead results from third-party micro-collection devices, causing unnecessary testing. All units affected.
Magellan DiagnosticsMar 13, 2026 - Lower riskMedical device
Magellan Diagnostics, Inc. recalls The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kit with mislabeled calibration buttons that may cause inaccurate lead test results. Affected lots include 2333M and variants. Consumers should check their kit's lot number and contact Magellan for guidance.
Magellan DiagnosticsFeb 23, 2024 - Lower riskMedical device
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits with certain lot numbers due to potential leaking or evaporation of reagents, which could cause false positive results for lead levels.
Magellan DiagnosticsSep 19, 2023 - Lower riskMedical device
Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Magellan recalls LeadCare Ultra Blood Lead Test Kit (Catalog 70-8098) due to potential underestimation of blood lead levels in patient samples. Affected units sold from 2011 to 2022.
MagellanMay 7, 2021 - Lower riskMedical device
Magellan Diagnostics, Inc. recalls Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog
Magellan recalls LeadCare II Blood Lead Test Kit (lot 1808M) due to calibration button defect causing false high lead levels. This affects professional blood lead testing devices.
MagellanAug 8, 2018 - Use cautionMedical device
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro
Magellan recalls LeadCare II Blood Lead Analyzers with specific part numbers due to risk of battery overheating and finger burns if removed while hot. Affected units may be used with caution after proper battery handling.
MagellanJan 9, 2018
Magellan Diagnostics, Inc. recall questions
How many recalls has Magellan Diagnostics, Inc. had?
12 recalls from Magellan Diagnostics, Inc. are on record with U.S. safety agencies, from 2018–2026.
What is the most recent Magellan Diagnostics, Inc. recall?
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762., dated Sep 4, 2026. Every Magellan Diagnostics, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Magellan Diagnostics, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Magellan Diagnostics, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.