On May 18th, 2017 the U.S. Food & Drug Administration administered a Class I recall of lead testing systems used on millions of children since the year 2014. This is the most serious type of recall given by the FDA. A recent article in the Cincinnati Enquirer is reporting that it is now eight months later and we still have no news on what went wrong.
The product that has been recalled is the Magellan Diagnostics LeadCare Plus and Ultra Blood Lead Testing Systems.
Laboratories, health care professionals, and of course patients being tested may be affected by this recall. In particular, children in high-risk environments with blood lead levels (BLL) in the 5 to 14 micrograms per deciliter range.
- Laboratories and health care professionals should follow recommendations in the FDA Safety Communication issued on May 17, 2017.
- Parents and at-risk adults are encouraged to follow the CDC’s recommendations listed in their Health Advisory issued on May 17, 2017.