BLOOD LEAD TEST SAFETY ALERT

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning laboratories and health care professionals not to use venous blood samples with Magellan Diagnostics LeadCare testing systems due to the potential for falsely low results. The CDC and FDA are assessing the potential public health risk of a negative bias associated with Magellan Diagnostics' analyzers. This safety alert applies to venous blood lead tests but does not apply to capillary blood lead tests collected by finger stick or heel stick. Physicians Laboratory began using the Magellan Diagnostics LeadCare system, which is an FDA approved test, beginning April 22, 2013 – present.

 

THE CDC RECOMMEND THAT THE FOLLOWING BE RETESTED:

  • Patients who are younger than 6 years (72 months) of age at the time of this alert (May 2017) and had a venous blood lead test result of less than 10 (ug/dL) from a test analyzed using a Magellan Diagnostics' LeadCare analyzer.
  • Women who are currently pregnant or nursing and were tested in this manner using a venous sample.

View more from the CDC

 

In order to obtain a list of patients from your practice that meet the above criteria, please contact Rick Noda at (402)731-4145 or rnoda@physlab.com.

 

THE FOLLOWING TEST CHANGES GO INTO EFFECT IMMEDIATELY:

806 - Lead, Blood (Capillary)

Specimen Requirements: 1.0mL (0.5 mL) Lavendar (EDTA) Microtainer.

Patient Demographics Form for Public Health Reporting Required.

Specimen Stability: Room Temperature 24 Hours.

Performed at Physicians Laboratory

 

2816 - Lead, Blood (Venous)

Specimen Requirements: 7 mL (0.5 mL) Royal Blue Metal Free Whole Blood (K2EDTA or Na2EDTA).

Patient Demographics Form for Public Health Reporting Required.

Specimen Stability: Room Temperature Indefinitely / Refrigerated Indefinitely.

Performed at ARUP

 

811 - Lead Industrial Exposure Panel, Adults (Previously - Lead/Zinc Protoporphyrin)

Specimen Requirements: 7 mL (2 mL) Royal Blue Metal Free Whole Blood (K2EDTA or Na2EDTA)

Patient Demographics Form for Public Health Reporting Required.

Specimen Stability: Room Temperature 30 Hours. Refrigerated 5 weeks.

Performed at ARUP