Details:

Corporate Authors:
Centers for Disease Control and Prevention (U.S.)
Description:
Distributed via the CDC Health Alert Network

November 5, 2021, 10:00 AM ET

CDCHAN-00457

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Update as an update to HAN Update 454: Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results that CDC issued on October 14, 2021. The purpose of this HAN Update is to clarify options for retesting children who were tested with the recalled LeadCare lead test kits. The information in this HAN Update remains the same as HAN Update 454, except for the new information added below in bold in the Recommendations for Clinicians section.

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 recallexternal icon, the most serious type of recall.


Subject:
[+]
"Lead/blood
Lead Poisoning/diagnosis
Mass Screening
Product Recalls And Withdrawals"

Series:
HAN ; 457
Document Type:
HAN Health Update
Name as Subject:
LeadCare® blood lead tests
Collection(s):
Health Alert Network (HAN)
Main Document Checksum:
[+]
urn:sha256:b67588eb25ea576d6560d1e9c682d8bca38d5249e9ef472f2baa4b7a85bb228f
File Type:

Supporting Files

• han00454.asp

  htm

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