The Food and Drug Administration and Magellan Diagnostics Inc. today expanded the ongoing recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests distributed between Oct. 27, 2020, and Aug. 19, 2021. FDA lists this as a Class I recall, the most serious type, due to a significant risk of falsely low results that could cause serious injuries, including in young children and pregnant individuals. FDA said clinicians should continue scheduled tests using other methods and retest children previously tested with a recalled kit. A replacement product is currently unavailable.

Related News Articles

Headline
Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week.…
Headline
Health care providers should not purchase or use certain imported medical gloves from certain companies, which appear to have been reprocessed, cleaned or…
Headline
The Food and Drug Administration today announced a Class 1 recall of battery packs for an intra-aortic balloon pump used with patients undergoing surgery…
Headline
The Food and Drug Administration today approved the first interchangeable biosimilar product for Humira, a monoclonal antibody used to treat certain…
Headline
Abbott Molecular Inc. yesterday issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and…
Headline
The Food and Drug Administration today announced it will withdraw regulations for non-drug manufacturers who produced during the COVID-19 public health…