Alerta De Seguridad para Streptex Group D Latex Lot number: 1154057

Safety alert

2013-04-18

2013-04-18

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130418.html

Medical device safety alert: thermo fisher scientific streptex group d latex, lot number: 1154057 medical device manufacturer, thermo fisher scientific, has issued a field safety notice concerning the streptex group d latex lot number: 1154057 sold separately as r30950901 lot number: 1149576 and contained within the kits detailed below: streptex latex agglutination test (200 tests) r30164701 lot number: 1187912 streptex latex agglutination test (50 tests) r30950501 lot number: 1192181 streptex latex agglutination test (50 tests) r30950901 lot number: 1149576 an internal technical investigation has confirmed that streptex group d latex lot: 1154057 sold separately as r30950901 lot: 1149576 and contained within the kits mentioned above may give weak or false negative test results. the positive control reagent continues to react satisfactorily with the latex and will not indicate that the reagent is weak. the manufacturer advises users to: i) destroy any remaining inventory of the lot listed above; ii) review results reported; iii) consider retesting and/or seek appropriate expert advice; and iv) contact customer services or local oxoid supplier who will issue a replacement. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 april 2013.