Calcium Gen.2 (CA2) 의 안전성 경고

Safety alert

2014-05-02

2014-05-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140502.html

Medical device safety alert: roche calcium gen.2 (ca2) medical device manufacturer, roche, has issued a field safety notice concerning calcium gen.2 (ca2). the affected catalogue numbers are 05061431190, 05061458190, 05061466190 and 05061474190. according to the manufacturer’s global complaint record, they received some customers complained of: duplicate and sens alarms during calibration, drop in quality control (qc) results , poor intermediate coefficient of variations (cv) for the ca2 (nm-bapta method) on the modular analytics analyzers. however, ca (gen.1) may seem to perform adequately. according to the manufacturer, it is assumed that the mentioned precision issue is due to the sensitivity of the ca2 assay to the maintenance condition of the modular analytics . on an analyzer maintained according to the manufacturer’s recommendations, the precision of ca2 should be within specifications. the manufacturer will implement a special hardware checking protocol to make sure the hardware condition of the system is satisfactory in the next preventative maintenance. furthermore, the manufacturer advises users to review their ca2 assay performance to see if they are affected by the mentioned symptoms. if users suspect that they are affected by the mentioned issue, the manufacturer advises them to perform a within run imprecision study (n=21) using qc materials for troubleshooting. the cv of the imprecision study should below 2%. then, users should contact the roche application representative with relevant data. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 2 may 2014.