Recall of LeadCare® Blood Lead Tests Due to Risk of Falsely Low Results, Update #1: Expanded Recall

On August 31, 2021, NH DHHS issued a health alert update on the recall of LeadCare blood lead tests.Key Points and Recommendations:

• Magellan Diagnostics, Inc. has expanded their product recall involving the LeadCare ® blood test kits. This expanded COOR-LO recall includes LeadCare® II Blood Test Kits lots: 2012M (Sublots -08, -09, -10, -11, -12, -13, and -14); 2018M; 2102M; 2109M, 2110M; 2111M; 2112M; 2113M; 2114M; and 2115M and is outlined below. These lots are in addition to previously recalled lots.
• Providers and healthcare organizations should discontinue use of all LeadCare® II testing supply kits and quarantine remaining inventory.
• Providers and healthcare organizations should identify and contact patients tested with recalled test kit lots.
  o All results tested on impacted lots should be confirmed with an alternative lead testing option analyzed using a high complexity testing method, such as Inductively
  Coupled Plasma Mass Spectrometry (ICP-MS) or Graphite Furnace Atomic Absorption Spectroscopy (GFAAS) and depending on availability may include:
  • Venous sampling
  • Capillary Microtainer (EDTA) tube
• The CDC has an instruction poster Steps for Collecting Finger Stick Capillary Blood Using a Microtainer® available.
• LeadCare analyzers are not impacted by the recall.
• Magellan Diagnostics has temporarily stopped shipments of LeadCare® test kits and has not issued a definitive date to resume shipments