Two warnings have been issued over Magellan Diagnostics Inc.’s lead testing systems. The first involved the LeadCare Plus and LeadCare Ultra testing systems and was deemed by federal regulators to be a Class I recall. This involved potentially incorrect lead blood levels when samples were obtained from a capillary or vein.
The second warning was issued over four of Magellan’s systems, the LeadCare Plus and the LeadCare Ultra, as well as the LeadCare and the LeadCare II. In this case, the issue involves blood samples obtained from veins.
LeadCare Plus and LeadCare Ultra Testing Systems’ Recall Deemed A Class I Recall
Medical device maker, Magellan Diagnostics Inc., recalled its LeadCare Plus and LeadCare Ultra Testing Systems because the systems may underestimate the blood lead levels (BLL) and provide inaccurate results. A falsely lower test result may lead to improper patient management and treatment for lead exposure or poisoning, according to the U.S. Food and Drug Administration (FDA).
The Magellan Diagnostics LeadCare Plus and the LeadCare Ultra Testing Systems are used to detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous).
The agency deemed the Magellan Diagnostics Inc. warning as a Class I recall, the agency’s most serious recall designation. A Class I recall means that use of the affected product, in this case the Magellan Diagnostics LeadCare Plus and LeadCare Ultra Testing Systems, may lead to serious adverse health consequences including serious injuries and death.
The recall involves all serial numbers and kit lot numbers for Magellan Diagnostics’ LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems that were manufactured from September 2013 to present and were distributed from September 2014 to present. A total of 1,089,984 of the systems were recalled in the United States.
The FDA indicates that laboratories that use Magellan’s LeadCare Testing Systems as part of diagnostic applications and laboratory personnel who interpret the results of Magellan’s LeadCare Testing Systems may be affected. Also, health care professionals who perform lead tests using Magellan’s LeadCare Testing Systems and patients being tested for elevated BLLs with Magellan’s LeadCare Testing Systems are impacted, specifically, children in high-risk environments with BLL in the five to14 micrograms per deciliter (µg/dl) range.
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LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra Testing Systems Recalls Deemed A Class I Recall
This recall accompanies the FDA’s prior Safety Communication concerning Magellan’s LeadCare Plus and Ultra Testing Systems, which are two of four blood lead testing systems that are now impacted by the recommendations made by the FDA. The second warning advises against using the Magellan Diagnostics LeadCare Testing systems with blood that is obtained from a vein. The warning applies to all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples in the United States. Magellan Diagnostics Inc. manufactures the following lead testing systems that are affected by the warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra.
The FDA notes that the Magellan’s LeadCare II is a point-of-care (CLIA-waived) blood lead testing system on which users test capillary blood samples for the most part; however, some laboratories process venous blood samples with this system, which is why this safety communication includes all Magellan LeadCare Testing Systems. The LeadCare Testing Systems are used in clinical laboratories, doctor’s offices, clinics, and hospitals nationwide.
The FDA is warning these facilities that Magellan Diagnostics’ LeadCare Testing Systems may underestimate BLLs and give inaccurate results when processing venous blood samples. The FDA strongly urges parents and at-risk adults to speak with their health care provider about the CDC’s recommendations on re-testing. Meanwhile, the FDA is also providing recommendations to help minimize risks for inaccurate test results to ensure patients receive accurate information concerning possible lead exposure.
The FDA is advising laboratories and health care professionals to follow recommendations in this Safety Communication and not prior communications from Magellan Diagnostics on its LeadCare Test Systems, including Magellan’s most recent Field Safety Correction Notification, dated April 28, 2017. Current information indicates that Magellan Diagnostics’ LeadCare Testing Systems may underestimate BLLs and provide inaccurate results when processing venous blood samples.
The FDA indicates that it does not have evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples and notes that it also has no reason to believe that other lead tests, including those using mass spectrometry, are affected by this issue.
The FDA provided the following Magellan Diagnostic history regarding its LeadCare systems:
- August 2014: Magellan reports initially recognized possible problems with the performance of its LeadCare Ultra and notified customers by letter on November 24, 2014, instructing facilities to implement a 24-hour incubation step with the blood sample to minimize and resolve what it noted was a low risk of underestimation of BLL.
- November 4, 2016: Magellan notified customers of similar problems when processing venous blood samples with its LeadCare II testing systems and recommended a four-hour incubation period for blood collection tubes received by laboratories from other facilities.
- November 11, 2016: Magellan advised customers that the rubber caps for the Becton Dickinson’s (BD) K2-EDTA Vacutainer blood collection tubes may introduce a substance into the blood sample when used with the LeadCare II systems. Facilities were advised to implement a minimum four-hour incubation step with the blood sample to mitigate rubber cap exposure.
- April 28, 2017: Magellan notified customers that they should no longer use BD blood collection tubes with lavender- or tan-colored tops with the LeadCare Ultra and Plus systems and should discontinue the 24-hour incubation step.
The FDA’s review of Magellan’s data supporting the issues discussed in its customer notifications did not confirm a root cause—including the tubes—for the inaccurate results. The FDA notes that it found a lack of reliable data identifying the root cause of the problem, the frequency and extent of inaccurate test results for the LeadCare Testing Systems, and a lack of adequate efficacy to support the mitigating steps taken by Magellan.
The FDA recommends laboratories and health care professionals discontinue using Magellan’s’ LeadCare System Testing Systems with venous blood samples. All LeadCare systems may be used with capillary blood samples at this time. Should laboratories or health care professionals be concerned about using the LeadCare Test Systems, the alternative options are mass spectrometry or atomic absorption methods.
The FDA recommends patients, caregivers, and at-risk adults follow the CDC’s recommendations concerning necessary re-testing based on the current safety communication, including that parents discuss re-testing with their health care provider or health department to determine if their child’s blood should be re-tested, that health care professionals re-test currently pregnant or lactating women who underwent a venous blood lead test performed using a Magellan’s LeadCare System Testing System, and that health care professionals re-test patients who are younger than six years of age on May 17, 2017 and who had a venous blood lead test result of less than 10 (µg/dL) from a test analyzed using a Magellan Diagnostics’ LeadCare analyzer.
The FDA wrote that it “is aggressively investigating the root cause of this issue with the manufacturers, health care facilities, and the CDC and will update this safety communication as critical information becomes available.”
Filing a Defective Lead Test Lawsuit
If you or someone you know suffered an injury related to a defective or recalled lead test system and want to learn more about filing a medical device injury lawsuit, contact an experienced personal injury attorney at Parker Waichman today. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).