Аналіз інформації за період 01.02.2016 – 31.03.2016, отриманої з іноземних систем повідомлення про продукцію, що становить серйозний ризикОпубліковано 04.04.2016 о 00:00
· Estradiol immunoassays – interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results
Manufactured by Siemens Healthcare Diagnostics Inc. / Siemens Healthcare Diagnostics Ltd and Roche Diagnostics GmbH- assay interference from the drug fulvestrant (Faslodex®) may cause falsely elevated estradiol results. Both Siemens and Roche have issued field safety notices (FSNs) highlighting this issue.
Alert type: Medical device alert Medical specialism: Critical care Issued: 24 March 2016
· All ZeniPower mercury-free hearing aid batteries – low risk of batteries exploding during use or if depleted
Manufactured by Zhuhai Zhi Li Battery Co Ltd – stop using batteries with certain best before dates (MDA/2016/003)
Alert type: Medical device alert Medical specialism: General practice and 1 others Issued: 10 March 2016
· Ambulatory syringe pumps (T34 and T60) and syringe extension sets used with the T34 pump, manufactured by Caesarea Medical Electronics (CME).
CME has recommended the need for protection of these pumps when exposed to direct sunlight. In addition, due to connector leakages, the manufacturer is recalling extension sets (specific product codes and batches) used with the T34 pumps (MDA/2016/002)
Alert type: Medical device alert Medical specialism: Critical care Issued: 2 March 2016