Safety alert against LeadCare Testing Systems by Magellan Diagnostics due to inaccurate test results

Access to the full content of this site is available only to registered healthcare professionals. Register to read more

ISSUE: The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the CDC to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples. The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities and the CDC, and will update this safety communication as critical information becomes available.  For more information please refer to the Safety Communication.

BACKGROUND: Magellan Diagnostics Inc. manufactures the following lead testing systems affected by this warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra.

The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). This warning applies to all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States.

Note: Magellan's LeadCare II is a point-of-care (CLIA-waived) blood lead testing system on which users mostly test capillary blood samples. However, some laboratories also process venous blood samples with the LeadCare II system, which is why this safety communication includes all Magellan LeadCare Testing Systems.

The LeadCare Testing Systems are used in clinical laboratories,...

Recommended for you

  • MedWatch Drug Updates
  • 1 comment

FDA update: Type III endoleaks associated with the use of endovascular graft systems

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA update: High risk of mortality and neurological adverse events when using SynCardia's TAH-t C2 Driver System

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Bridge Occlusion Balloon Catheter Model 590-001 by Spectranetics: Blocked guidewire lumen

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Intralipid 20 % IV Fat Emulsion by Baxter: One lot of product exposed to subfreezing temperature

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Aliqopa (copanlisib) for the treatment of relapsed follicular lymphoma

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Mvasi (bevacizumab-awwb) for the treatment of cancer

Read more
  • MedWatch Drug Updates
  • 1 comment

Case of HORV reported after intraocular Inj of a compounded triamcinolone, moxifloxacin, vancomycin

Read more
  • MedWatch Drug Updates
  • no comment

FDA alert- Not to use infant sleep positioners as it can cause suffocation

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA recommends separate dosing for Kayexalate (sodium polystyrene sulfonate) from all other oral drugs

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I Recall of Intra-Aortic Balloon Pump by Datascope/MAQUET- False blood detection alarm and ingress of fluid into the pump

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA statement on risks of unapproved use of Keytruda (pembrolizumab) for treatment of multiple myeloma

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Piyanping Anti-Itch Lotion by Lucky Mart Inc.: Contain wrong active pharmaceutical ingredient

Read more
  • FDA Drug Updates
  • no comment

FDA approves Besponsa (inotuzumab ozogamicin) for acute lymphoblastic leukemia

Read more
  • MedWatch Drug Updates
  • no comment

FDA alert: Incorrect dosing of Ocaliva (obeticholic acid) associated with increased risk of serious liver injury

Read more
  • MedWatch Drug Updates
  • no comment

FDA advise on use of opioid addiction medication in patients taking benzodiazipines or CNS depressants

Read more
  • FDA Drug Updates
  • 1 comment

New targeted treatment approved for relapsed or refractory acute myeloid leukemia

Read more
  • MedWatch Drug Updates
  • 1 comment

Class I recall of Penumbra 3D Revascularization device by Penumbra: delivery wire may break or separate during use

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Hepatitis C

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of VV28F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical- Extension tube may separate from hub

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Nerlynx (neratinib) for breast cancer

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Diabetes Infusion Sets by Medtronic -Vent Membrane susceptible to blocking by fluid

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Baby Organic Liquid Formula by Garden of Life: Misleading direction for use

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Endari (L-glutamine) for sickle cell disease

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Atar Extension Cables by Oscor- cable malfunction interrupting the pacing system

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Novopen Echo Insulin Delivery Device by Novo Nordisk: Chemical exposure may damage cartridge holder

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Activase (alteplase) 100mg by Genentech due to lack of sterility assurance

Read more
  • FDA Drug Updates
  • 1 comment

FDA approved Haegarda (C1 esterase inhibitor) for Hereditary Angioedema

Read more
  • MedWatch Drug Updates
  • 1 comment

Recall of Oxytocin compounded with either Lactated Ringers or Lactated Ringers and Dextrose by PharMEDium

Read more
  • MedWatch Drug Updates
  • 1 comment

FDA Alert- Not to use Alcohol Pads or Benzalkonium Chloride Antiseptic Towelettes by Foshan Flying Medical Products

Read more
  • MedWatch Drug Updates
  • 1 comment

Field Correction of system CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope

Read more