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U.S. Department of Health and Human Services

Class 1 Device Recall LeadCare Plus Blood Lead Testing System

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  Class 1 Device Recall LeadCare Plus Blood Lead Testing System see related information
Date Initiated by Firm November 29, 2014
Create Date May 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-1926-2017
Recall Event ID 76991
510(K)Number K142705  
Product Classification Lead, atomic absorption - Product Code DOF
Product Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits
Part Number: 80-0010
Code Information Kit lots:, 1309BU,1310AU,1312BU,1404AU,1408BU
Recalling Firm/
Manufacturer
Magellan Diagnostics, Inc.
101 Billerica Ave Bldg 4
North Billerica MA 01862-1271
For Additional Information Contact SAME
978-856-2339
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action The firm, Magellan Diagnostics, notified customers by letter dated Nov 29, 2014 and provided with the problem, mitigation action( customers have been advised to implement a minimum 24-hour incubation of the blood-treatment reagent mixture prior to analysis) . Customers were instructed to return a completed FaxBack form via fax to 978-600-1480. A revised letter issued May 1, 2017 recommending that customers make the following workflow changes: 1. Discontinue collecting blood samples for lead testing in Becton Dickinson (BD) EDTA Vacutainer¿ tubes: Lavender and Tan tops. 2. Discontinue the 24 hour incubation for sample preparation. Questions contact : 978-250-7072 or rmorse@magellandx.com. On 5/17/17 FDA issued News Release - FDA warns Americans about risk of inaccurate results from certain lead tests- manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.
Quantity in Commerce 1016
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DOF and Original Applicant = Magellan Diagnostics
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