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U.S. Department of Health and Human Services

Class 1 Device Recall The LeadCare Ultra Blood Lead Testing System

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  Class 1 Device Recall The LeadCare Ultra Blood Lead Testing System see related information
Date Initiated by Firm November 29, 2014
Date Posted May 18, 2017
Recall Status1 Completed
Recall Number Z-1925-2017
Recall Event ID 76991
510(K)Number K123563  
Product Classification Lead, atomic absorption - Product Code DOF
Product Magellan Diagnostics LeadCare Ultra Blood Analyzer

Part Number: 80-0010
Code Information All serial numbers
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 Magellan issued a follow-on Recall notification related to the FDA Safety Notification dated May 17, 2017. This current recall follows FDAs recommendation to remove venous blood samples as an allowable sample type from all LeadCare products. This recall will supersede and replace the prior Recall notifications. Notifications issued by : UPS Letter (US), Registered Letter, E-mail, or Phone calls form May 23-May 25. Questions: Reba Daoust, Director of QA/RA 978-248-4811 or rdaoust@magellandx.com Refer to Firm's website: http://www.leadcare2.com/getmedia/2fd8a90f-5c64-4058-b6ab-5db13512f0fe/Letter-to-our-customers-5-17-17.pdf.aspx. The notification of May 2017 supercedes the firms previous communications:. 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. 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. Blood drawn from a vein may provide results that are lower than the actual level in the blood. FDA is warning laboratories not to use Magellan Diagnostic lead tests wit blood drawn from the vein. At this time all Leadcare systems can be used with blood drawn from a finger or heel stick. Based on FDA/s warning the firm issued notification letter to users on 5/xx/17.
Quantity in Commerce 49 units
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.
510(K) Database 510(K)s with Product Code = DOF and Original Applicant = MAGELLAN DIAGNOSTICS
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