Class I Recall of Magellan Diagnostics Inc. LeadCare Plus and Ultra Testing Systems
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 the affected product may cause serious adverse health consequences.
This recall accompanies the U.S. Food and Drug Administration's (FDA's) Safety Communication (See StayAlert! Notice published on May 17, 2017) and the Centers for Disease Control and Prevention’s (CDC's) Health Alert (See StayAlert! Notice published on May 19, 2017). Magellan's LeadCare Plus and Ultra Testing Systems are two of four blood lead testing systems affected by the recommendations in the FDA's Safety Communication.
The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. They are conducting studies with the CDC to identify the cause and better characterize the extent of the problem.
Who May be Affected
- Laboratories that use Magellan's LeadCare Testing Systems as part of diagnostic applications.
- Laboratory personnel who interpret the results of Magellan's LeadCare Testing Systems.
- Health care professionals who perform lead tests using Magellan's LeadCare Testing Systems.
- Patients being tested for elevated BLLs with Magellan's LeadCare Testing Systems, in particular children in high-risk environments with BLL in the 5 to14 micrograms per deciliter (µg/dl) range.
What to Do
On May 24, Magellan Diagnostics Inc. sent a “Customer Safety Communication” letter to all affected customers. The letter provided the following information:
- Do NOT use venous blood samples with any LeadCare Blood Lead Testing System.
- Capillary blood samples are permitted for use with the LeadCare Blood Lead Testing Systems, for example:
- Capillary tubes shipped in LeadCare II test kits
- RAM Scientific SAFE-T-FILL capillary collection tubes
- Complete the “Fax Form Record: Notification on LeadCare Systems” and return it by fax 978-600-1480 or 888-789-8040. Or, fill out the online version of the form, available at http://www2.magellandx.com/fda
- Share this safety information with appropriate personnel and retain a copy of the letter.
The FDA recommends laboratories and health care professionals take the following actions:
- Discontinue using Magellan's LeadCare Testing Systems with venous blood samples. At this time, all LeadCare systems can be used with capillary blood samples.
- Laboratories and health care professionals should follow recommendations in the FDA Safety Communication issued on May 17, 2017 rather than previous communications from Magellan Diagnostics on their LeadCare Testing Systems, including Magellan's Field Safety Correction Notification dated April 28, 2017.
- Report any adverse events to the FDA and to Magellan Diagnostics.
- If laboratories or health care professionals are concerned about using the LeadCare Testing Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests, and may be available only from larger-capacity laboratories such as reference labs.
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