Magellan Diagnostics, Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

Magellan Diagnostics, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Magellan Diagnostics, Inc.

Date Product Reason Class
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labele... Class II
Sep 19, 2023 LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test ki... During an internal audit a small percentage (<10%) of plastic caps used to cl... Class II
May 7, 2021 LeadCare II Blood Lead Test Kit Catalog Number 70-6762 Magellan has received reports that control tests of either the Low-Control an... Class I
May 7, 2021 LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004 Magellan has received reports that control tests of either the Low-Control an... Class I
May 7, 2021 LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098 Magellan has received reports that control tests of either the Low-Control an... Class I
Aug 8, 2018 Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement ... Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality... Class II
Jan 9, 2018 LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the q... The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead... Class II
Jan 9, 2018 LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P,... The incorrect placement of AA batteries into certain LeadCare II Blood Lead A... Class II
May 23, 2017 Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product U... Underestimates the lead concentration of venous blood samples when the sample... Class I
May 23, 2017 Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: ... Underestimates the lead concentration of venous blood samples when the sample... Class I
Jan 20, 2016 LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Prod... LeadCare II Test Kits controls out of range Class II
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate fals... Class I
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate fals... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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