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Recall Observatory FDA recall evidence

Device 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.

Z-2226-2017

May 23, 2017

Class I

Product summary

Firm
Magellan Diagnostics, Inc.
Event
Event 77211
Status
Terminated
Classification
Class I
Quantity
6018 kits (total)= 5818 (US)and 200 (OUS)
Official record key
device-enforcement:Z-2226-2017

Official wording

Reason: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems

Code information: All lot codes

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems