Magellan Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2226-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: May 23, 2017

Date Posted: June 14, 2017

Recall Number: Z-2226-2017

Event ID: 77211

Reason for Recall:

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

Status: Terminated

Product Quantity: 6018 kits (total)= 5818 (US)and 200 (OUS)

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

Voluntary or Mandated:

Voluntary: Firm initiated