Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for

FDA device recall Z-2226-2017 · posted 2017-06-05 · Terminated

Recall details

Recalling firm: Magellan Diagnostics, Inc.
Reason for recall: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Action taken: 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
Root cause: Device Design
Status: Terminated
Product code: DOF
Quantity affected: 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 NETHE
Date initiated: 2017-05-23
Date posted: 2017-06-05
Date terminated: 2021-07-08
Location: North Billerica, MA

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Record	Firm	Date
LEADCARE II BLOOD LEAD TESTING SYSTEM (K052549)	Esa Biosciences, Inc.	2005-10-06