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.