Z-1926-2017 Class I Terminated
FDA device recall Z-1926-2017 was initiated by Magellan Diagnostics, Inc. on November 29, 2014 and is designated Class I. Reason for recall: 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 tubes with lav… The recall status is terminated (terminated February 26, 2022). Affected quantity: 1016.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- November 29, 2014
- Termination Date
- February 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1016
Product Description
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Reason for Recall
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 tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
Distribution Pattern
Nationwide Distribution
Code Information
Kit lots: 1309BU,1310AU,1312BU,1404AU,1408BU