Important Safety Alerts

Medical device manufacturer, Remel Europe Limited (part of Thermo Fisher Scientific), has issued a medical device safety alert concerning its Thermo Scientific Remel Salmonella paratyphi A-H Stained Suspension. The affected products are identified as below:

• Product Code: R30855101
• Bottle Lot Number: 2169556
• Carton Lot Number: 2184561, 2308897, 2228271, 2213610 & 2258333

According to the manufacturer, an internal technical investigation has determined that the Salmonella paratyphi A-H Stained Suspension (R30855101) is showing granularity, upon dispensing, which may be misinterpreted as a positive result when used according to the Instructions For Use (IFU).

The clinical risk is extremely low based on the following rationale:

• The serological test method is performed primarily for epidemiological purposes, and will not have any direct clinical effect critical to patient care. The tests should be used in parallel with appropriate culture techniques for the isolation and identification of the causative organism;
• Any risk to patients is indirect, in that epidemiology in a population may not be profiled accurately.

The affected users are advised to take the following actions:

• Review any remaining inventory of Salmonella paratyphi A-H Stained Suspension (R30855101);
• Requirement for review of reported test results should be determined by the appropriate technical expert.

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 23 May 2018