Simplifying Global Compliance
FDAnews Device Daily Bulletin
Analyzer Recalled Due to False Results
Feb. 10, 2012
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert
for Hitachi’s Cobas c501/ 502 laboratory analyzer. The use of insufficient volumes of reagent may lead to a false negative result such as a missed diagnosis of syphilis, a delayed diagnosis of organ rejection or a delayed diagnosis of the end of remission for malignant lymphoma patients.
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