Remel Vibrio cholerae Inaba agglutinating serum 의 안전성 경고

Safety alert

2013-06-28

2013-06-28

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130628.html

Medical device safety alert: thermo fisher scientific remel vibrio cholerae inaba agglutinating serum medical device manufacturer, thermo fisher scientific, has issued a field safety notice concerning remel vibrio cholerae inaba agglutinating serum (model no.: zm06/r30165101 and lot no.: 1155581). according to the manufacturer, an internal technical investigation has confirmed that the performance of vibrio cholerae inaba agglutinating serum lot: 1032772 sold separately as r30165101 lot: 1155581 has deteriorated, and is no longer agglutinating with positive cultures in the slide and tube agglutination test. the manufacturer advises customers who have used the affected lot of vibrio cholerae inaba agglutinating serum to review results reported and consider retesting and/or seek appropriate expert advice as a false negative result may have been obtained. furthermore, the manufacturer requests users to destroy any remaining inventory of the affected vibrio cholerae inaba agglutinating serum and contact customer services or local distributor to request replacement product. according to the manufacturer, the affected products were distributed to hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 28 june 2013.