PlainRecalls

Magellan Diagnostics, Inc.

Compiled from official public sources by the publisher.

16 recalls on record · Latest: Apr 29, 2026

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Agency notice ledger

Federal filing book Magellan Diagnostics, Inc. LIGHT-BOOK · SINGLE-AGENCY

#980 of 14,151 · 16 notices · 0.015% archive

  • BOOK 16 notices
  • RANK #980 of 14,151
  • SHARE 0.015% archive
  • AGENCY FDA Devices (16)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 29, 2026
  • PHOTO Acella Pharmaceutical…

Nearest notice-volume peer: Acella Pharmaceuticals, LLC (0 notice gap)

Magellan Diagnostics, Inc. accounts for about 0.015% of the 104,423-notice archive on 16 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Magellan Diagnostics, Inc. sits among 14,151 recalling firms

Magellan Diagnostics, Inc. ranks 980th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Magellan Diagnostics, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

16 980th of 14151 higher than 13,145 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Magellan Diagnostics, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Magellan Diagnostics, Inc. holds about 0.015% of archive notices alongside 16 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 29, 2026

LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
FDA Devices Moderate Apr 29, 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): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer
FDA Devices Moderate Apr 29, 2026

LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
FDA Devices Moderate Dec 3, 2025

The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50) " Transfer Droppers (50) " Calibration Button (1) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)
FDA Devices Moderate Nov 15, 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 whole blood.
FDA Devices Critical Jul 7, 2021

LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
FDA Devices Critical Jul 7, 2021

LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
FDA Devices Critical Jul 7, 2021

LeadCare II Blood Lead Test Kit Catalog Number 70-6762
FDA Devices Moderate Nov 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
FDA Devices Moderate Apr 11, 2018

LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
FDA Devices Moderate Apr 11, 2018

LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
FDA Devices Moderate Aug 23, 2017

LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls (two levels), heparinized capillary tubes and plungers, transfer droppers and a calibration button. The LeadCare II Lead Controls packaged in the kit lots listed in #2 below are the subject of this recall (Field Correction) action.
FDA Devices Critical Jun 14, 2017

Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
FDA Devices Critical Jun 14, 2017

Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare 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 this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
FDA Devices Critical May 24, 2017

Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
FDA Devices Critical May 24, 2017

Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010

Magellan Diagnostics, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Cell Marque Corporation 16 Churchill Medical Systems, Inc. 16 Flower Orthopedics Corporation 16 Greatbatch Medical 16

Frequently Asked Questions

How many federal recall notices name Magellan Diagnostics, Inc.? ▼
PlainRecalls indexes 16 distinct federal recall events naming Magellan Diagnostics, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Magellan Diagnostics, Inc. sit among other recalling firms? ▼
Magellan Diagnostics, Inc. ranks #980 of 14,151 by distinct recall-event count among 14,151 firms in this archive (93rd percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Magellan Diagnostics, Inc.'s notices? ▼
FDA Devices accounts for 16 of this firm's 16 indexed notices.
What product category dominates Magellan Diagnostics, Inc.'s filing book? ▼
Filings for Magellan Diagnostics, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Magellan Diagnostics, Inc.: 16 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Magellan Diagnostics, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026