Safety Alert for LeadCare Testing Systems

Safety alert

2018-03-23

2018-03-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180323c.html

Medical device safety alert: magellan diagnostics leadcare testing systems (update) the united states food and drug administration (fda) has issued a statement on findings from ongoing investigation into lead testing issues and an updated medical device safety alert concerning leadcare testing systems, manufactured by magellan diagnostics. the fda has conducted investigations with magellan diagnostics as well as becton dickinson (bd), the manufacturer of blood sample collection tubes used alongside with the lead tests, to determine the cause of the inaccurate lead test results from the leadcare testing systems. the fda concluded that there was a significant chance of false results with magellan’s leadcare tests when used with whole blood collected from the vein and stored in certain bd tubes. upon further investigations, bd determined that the affected tubes’ rubber stoppers contain a chemical called thiuram that can release sulfur-containing gases that dissolve into blood samples and bind tightly to lead particles. this chemical reaction makes it difficult for the magellan lead tests to detect the correct amount of lead in a sample. the fda recommends laboratories and health care professionals take the following actions: discontinue using magellan's leadcare system testing systems with venous blood samples. at this time, all leadcare systems can be used with capillary blood samples. if they are concerned about using the leadcare test 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. for details, please refer to the fda website: https://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm602343.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm558988.Htm for information of our previous important safety alert, please refer to mdco website: http://www.Mdco.Gov.Hk/english/safety/recalls/recalls_20170518.Html if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 march 2018.