Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its SLIDEX Strepto Plus [Product Number: 58811; Lot Number: 1501111348; Expiration Date: 08-JAN-2016].

According to the manufacturer, a customer complaint investigation confirmed a stability issue associated with SLIDEX Strepto Plus Latex B reagent (lot# 1501111348) when exposed to thermal shock conditions either during transportation or storage. Product exposed to thermal shock exhibited weak or no agglutination. As a result of weak or no agglutination to the Latex B reagent, there is a potential for a false negative result with Group B Streptococcus colonies. Product that was stored under normal conditions was determined to perform within specifications and produce proper agglutination.

In order to determine whether the product is affected by this issue, affected users are instructed to perform the following steps:

• Prior to each use with clinical samples, perform the Quality Control procedure referenced within the Package Insert using the positive controls.
• If the product produces a positive result with the positive controls, as described in the "Readings and Interpretation of Results" section of the Package Insert, then utilize the product to process the clinical sample(s).
• If the product produces a negative result with the positive controls, as described in the "Readings and Interpretation of Results" section of the Package Insert, then discontinue use of that kit of the product, dispose of the affected product.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 28 October 2015