Important Safety Alerts

Medical device manufacturer, Thermo Fisher Scientific issued a medical device safety alert concerning RemelStreptex Group D Latex Reagent with model number R30950901 and lot number 1215767.

According to the manufacturer,an internal technical investigation has confirmed that Streptex Group D Latex Lot: 1215767 sold separately as R30950901 Lot: 1215642 and contained within the kits detailed below, may give weak or false negative test results:

• Streptex Latex Agglutination Test (200 tests) R30164701 Lot: 1215568
• Streptex Latex Agglutination Test (50 tests) R30950501 Lot: 1215567
• Streptex Latex Agglutination Test (50 tests) R30950901 Lot: 1215642

The positive control reagent continues to react satisfactorily with the latex and will not indicate that the reagent is weak. Continued use of these kits may result in false negative test results with some cultures.

The manufacturer advises the affected customers to:

• destroy any remaining stock;
• contact Customer Services or local Oxoid supplier who will issue a replacement;
• review results reported using this lot; and
• consider retesting and/or seek appropriate expert advice.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 9 April 2013