Advice
Regulatory information
Regulatory information
A search of the Medicines and Healthcare products Regulatory Agency website revealed that 2 manufacturer field safety notices have been issued for Buhlmann faecal calprotectin tests. One of these was for an incorrect assay date with Quantum Blue; the other was for positive bias with the CALEX Cap extraction device and corrective action with CALEX Cap "N" (used with IBDoc and Quantum Blue).
No other field safety notices or medical device alerts were identified for the technologies in this MIB.