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U.S. Department of Health and Human Services

Class 1 Device Recall LeadCare II Blood Lead Testing System

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  Class 1 Device Recall LeadCare II Blood Lead Testing System see related information
Date Initiated by Firm May 23, 2017
Date Posted June 05, 2017
Recall Status1 Open3, Classified
Recall Number Z-2226-2017
Recall Event ID 77211
510(K)Number K052549  
Product Classification Lead, atomic absorption - Product Code DOF
Product Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits.
Product Usage:
The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
Code Information All lot codes
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
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
FDA Determined
Cause 2
Device Design
Action Magellan issued a Safety Notification letter from May 23-25, 2017 . The firm states following the FDA Safety Notice, published May 17, 2017, this notification is to advise your facility regarding a change to existing LeadCare product usage and labeling. Prior instructions for use included capillary and venous blood samples. However, because the LeadCare Testing Systems may underestimate blood lead levels and give inaccurate results when processing venous blood samples, the FDA recommends discontinuing the use of venous blood samples with any LeadCare Blood Lead Testing System (LeadCare, LeadCare II, LeadCare Ultra, LeadCare Plus). Capillary samples may still be used on all LeadCare prducts listed above. Users requested to complete/sign Fax Form Record to verify that you have read and understood the Safety Communication to Customers on page 1. Contact Reba Daoust, Director of QA/RA 978-248-4811 or rdaoust@magellandx.com
Quantity in Commerce 6018 kits (total)= 5818 (US)and 200 (OUS)
Distribution Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM
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 = ESA BIOSCIENCES INC.
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