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Friday, July 10, 2009

Covidien unit recalls red blood cell diagnostic agent

By Mass High Tech staff

A subsidiary of Mansfield-based medical device and pharmaceuticals maker Covidien plc has pulled from the market one lot of a radiopharmaceutical diagnostic agent after finding it to be less than effective. St. Louis-based Mallinckrodt Inc. has voluntarily recalled a single lot of Sodium Chromate Cr-51 Injection, a tool to diagnose red blood cell volume, mass and survival time.

The recall follows company findings of the potential for false low red blood cell volume readings. With a potential misdiagnosis, patients could be exposed to greater risk of blood clots or stroke, Mallinckrodt officials said.

To date, 84 percent of the impacted vials have been recovered from customers in the U.S., Canada and Mexico. The company has received no complaints of ill side effects.

Mallinckrodt’s parent company, Covidien (NYSE: COV), announced in June that it had completed its move of headquarters from Bermuda to Ireland. Worldwide, Covidien employs 41,000 workers in 59 countries. The company develops medical devices, imaging solutions, pharmaceutical products and medical supplies.

 

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