Company: Magellan Diagnostics Inc.
Date of Enforcement Report: 5/24/2017
Class I:
PRODUCT
Magellan Diagnostics Inc. Recalls LeadCare Plus and Ultra Testing Systems Due to Inaccurate Test Results.
The LeadCare Plus and the LeadCare Ultra Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous).
Recall Number: Z-1296-2018
REASON
Magellan Diagnostics is recalling the LeadCare Plus and the LeadCare Ultra Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning. The use of affected product may cause serious adverse health consequences.
This recall accompanies FDA’s safety communication from May 17, 2017. Magellan’s LeadCare Plus and Ultra Testing Systems are two of four blood lead testing systems affected by the recommendations in FDA’s safety communication.
The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.
Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.
RECALLING FIRM/MANUFACTURER
Abbott-Thoratec on 4/12/2017. Voluntary: Firm Initiated recall is on-going.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
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