Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results [October 14, 2021, 10:00 AM ET]

Details

• Corporate Authors:
  Centers for Disease Control and Prevention (U.S.). Health Alert Network (HAN)
• Description:
  October 14, 2021, 10:00 AM ET
  
  CDCHAN-00454
  
  Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued notifications about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020, to August 19, 2021. Additional LeadCare II product lots, including lots previously reported to be unaffected, were recalled due to a significant risk of falsely low results. The use of these devices may cause serious injuries because they might underestimate blood lead levels. FDA has identified this as a Class I recall, the most serious type of recall.
  
  The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Update to notify healthcare providers and state and local health departments about the expansion of the recall notice and to recommend appropriate follow-up actions in the shortage of LeadCare Lead Tests. This HAN Health Update is an update to HAN Health Advisory 445: Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results that CDC issued on July 6, 2021.
  
  
• Content Notes:
  Notice of Possible Alert Expiration: The CDC Health Alert, Advisory, Update, and Info Service announcements, distributed by the Health Alert Network (HAN), were active on the date they were originally published. Publication dates have been added to Titles for clarity. A CDC Health Alert, Advisory, Update, and Info Service announcement may expire at any time. They may also be updated or superseded according to later developments. None of the CDC Health Alert, Advisory, Update, or Info Service announcements in the Stacks HAN Collection should be assumed to be current or active. Stacks preserves HAN announcements in order to maintain a record of past CDC actions. Stacks in not designed for up-to-the-minute notifications. For the list of current CDC Health Alert, Advisory, Update, or Info Service announcements, patrons should visit the Health Alert Network (HAN) webpage at https://www.cdc.gov/han/php/about/index.html. For up to the minute reports, subscribe to the HAN email alert system hosted by CDC News & Updates at https://tools.cdc.gov/campaignproxyservice/subscriptions.aspx?topic_id=USCDC_486
  
  Categories of Health Alert Network (HAN) messages:
  
  Health Alert: Requires immediate action or attention, highest level of importance.
  
  Health Advisory: May not require immediate action; provides important information for a specific incident or situation.
  
  Health Update: Unlikely to require immediate action; provides updated information regarding an incident or situation.
  
  HAN Info Service: Does not require immediate action; provides general public health information.
  
  
• Subjects:
  Lead/blood Lead Poisoning/diagnosis Mass Screening Product Recalls And Withdrawals
• Keywords:
  HAN Health Alert Network
• Source:
  HAN ; 454
• Series:
  Health Alert Network
• Subseries:
  CDC Health Update
• Publisher:
  Centers for Disease Control and Prevention (CDC) (U.S.)
• Document Type:
  Text
• Genre:
  Alert
• Place as Subject:
  United States
• Rights:
  Public Domain
• Issue:
  00454
• Collection(s):
  Health Alert Network (HAN)
• Main Document Checksum:
  urn:sha-512:ea0b3a71abf0ffa8c594dde205d7921ee276c0a6574e3d097dc2773af1a6fb89b8537f81c26d7b414fe07399459092285b8536ee317cd74ac3edbb11b49e85fe
• Download URL:
  https://stacks.cdc.gov/view/cdc/110668/cdc_110668_DS1.pdf
• File Type:
  [PDF - 179.67 KB ]