Important Safety Alerts

Medical device manufacturer, PTS Diagnostics, has issued a medical device safety alert concerning its PTS Panels CHOL+GLU test strips [Lot Numbers: A705 and A707].

Based on the results of the manufacturer's internal testing, there is potential for under-recovery of the glucose analyte, and therefore, potential for lower glucose test results.

According to the manufacturer, the affected lots were shipped during the timeframe of April 19 to June 2, 2017. The correction is being conducted due to potential for loss of activity of the glucose analyte prior to the full stated shelf life (August 2018).

The manufacturer has decided to remove remaining product from the market. The affected customers are requested to take the following actions:

• Immediately check their inventories and, if they have further distributed this product, identify the users and notify them at once of this product recall.
• Any materials from the affected lot numbers that are at their facility and/or their users' facilities should be immediately segregated and destroyed in such a manner as to prevent further use.

According to the manufacturer, the affected lot A705 is distributed in Hong Kong.

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

Posted on 19 March 2018