Lead testing
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Hello, I believe the only FDA-approved waived analyzer for Lead is the Magellan / Meridian Bioscience Lead Care II. We had it years ago and essentially lost confidence due to the numerous reagent recalls and pulled the test in Feb. 2024. Our providers are asking inquiring again as compliance with patients following up with a lab draw is poor. For those using that test, how have things been in the last few years? Thank you for your responses.
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We have been using this device for the past year and have encountered no issues. Magellan previous recall was for Venous specimen as it exhibits Negative bias. Now, they only allow capillary testing.