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:
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