Z-2225-2017 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- May 23, 2017
- Termination Date
- July 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,979 kits (total)= 153,447 (US)and 18532 (OUS)
Product Description
Magellan Diagnostics LeadCare and LeadCare II 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.
Reason for Recall
Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
Distribution Pattern
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
Code Information
All lot codes