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Update: Expansion of recall of LeadCare blood lead tests due to risk of falsely low results
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11/05/2021
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Series: HAN ; 457
[PDF-184.74 KB]
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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 recall external icon, the most serious type of recall.
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