Simplifying Global Compliance
FDAnews Device Daily Bulletin
Analyzer Recalled Due to False Results
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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