fda
11 records
FDA Device Recall: LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit i
2023-11-15
Class II — During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inad...
View Source
FDA Recall: Magellan Diagnostics, Inc. — Class I
20210707
Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the und | Product: LeadCare Ultra Blood Lead Test Kit Ca...
View Source
FDA Device Recall: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
2021-07-07
Class I — Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in pat...
View Source
FDA Device Recall: LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
2021-07-07
Class I — Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in pat...
View Source
FDA Recall: Magellan Diagnostics, Inc. — Class II
20180411
The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user c | Product: LeadCare II Blood Lead Analyzer Part ...
View Source
FDA Device Recall: LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 7
2018-04-11
Class II — The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batterie...
View Source
FDA Device Recall: LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quan
2018-04-11
Class II — The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batter...
View Source
FDA Recall: Magellan Diagnostics, Inc. — Class I
20170524
LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed | Product: Magellan Diagnostics LeadCare Ultra Bl...
View Source
FDA Device Recall: Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The
2017-06-14
Class I — Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
View Source
FDA Device Recall: Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
2017-05-24
Class I — LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tube...
View Source
FDA Device Recall: Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
2017-05-24
Class I — LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tube...
View Source
ny_corps
1 records
NY Corp: MAGELLAN DIAGNOSTICS, INC.
2017-10-20
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Delaware
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.