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Falsely Low Results Lead FDA To Affix Class I Designation To Recall Of Magellan Lead Tests

 
• By Shawn M. Schmitt

The LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests made by Magellan Diagnostics Inc. were recalled because falsely low results could cause health risks to children and pregnant people.

The word recall.

A recall by Magellan Diagnostics Inc. of its LeadCare diagnostic tests was designated as high-risk class I by the US Food and Drug Administration on 1 July.

The LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead Tests were recalled on 28 May (and the recall was...

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J&J’s Ethicon Issues Class I Correction For Echelon Stapler Reloads Amid Lockout Risk

 
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More from Policy & Regulation

FDA Panel Supports Dermal Fillers For Décolletage Use

 
• By Elizabeth Orr

An FDA panel has endorsed the use of dermal fillers for décolletage, but warned of patient safety concerns. The filler can cause complications with future imaging and pregnancy or breastfeeding, panelists said. Regulatory measures and patient studies are recommended for better outcomes.

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By Elizabeth Orr

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FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 
• By Brian Bossetta

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.