Recall of LeadCare® blood lead tests due to risk of falsely low results

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.
• Description:
  Distributed via the CDC Health Alert Network
  
  July 06, 2021, 12:00 PM ET
  
  CDCHAN-00445
  
  Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued a recall notice concerning the use of some LeadCare® Blood Lead Tests (certain LeadCare II, LeadCare Plus, and LeadCare Ultra test kit lots). These lots were distributed between October 27, 2020, and June 15, 2021. The use of these devices may cause serious injuries because they might underestimate blood lead levels. The FDA has identified this as a Class I recall, the most serious type of recall.
  
  The purpose of this Centers for Disease Control and Prevention (CDC) Health Alert Network (HAN) Health Advisory is to notify healthcare providers and state and local health departments about this recall notice and to recommend appropriate follow-up actions.
  
  
• Subjects:
  Lead/blood Lead Poisoning/diagnosis Mass Screening Product Recalls And Withdrawals
• Source:
  HAN ; 445
• Series:
  Health Alert Network
• Document Type:
  HAN Health Advisory
• Name as Subject:
  National Respiratory and Enteric Virus Surveillance System (U.S.) ; National Respiratory and Enteric Virus Surveillance System (U.S.)
• Issue:
  445
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:1aadeded5a14c42ba4a81c0c92ae641135f5895dce8573b946708c8de6585734b60ba0f4eda2c09cbbe455dfac3df087ad96e2eeb8bae0f503467f905642a774
• Download URL:
  https://stacks.cdc.gov/view/cdc/107703/cdc_107703_DS1.pdf
• File Type:
  [PDF - 187.53 KB ]