International Blood Screening Assay Recall (GPRO, NVS)
In July 2008, Gen-Probe Inc. (NASDAQ: GPRO) was notified that certain blood screening assays manufactured by the company for Novartis’ (NYSE: NVS) Vaccines & Diagnostics unit and sold outside of the United States might have been improperly stored at a Novartis warehouse in Singapore.
The company investigated the product performance and on August 12, 2008 Gen-Probe determined that it could not fully assess the potential impact of these improper storage conditions. The determination was being used to determine the ultimate performance of the product without conducting additional stability testing, which is expected to be completed over the course of the next 30 to 60 days.
Novartis and Gen-Probe agreed that products previously delivered to customers from this warehousing facility should be replaced and appropriate field actions were initiated with customers and the regulatory authorities in the affected countries.
The affected products include Novartis’ PROCLEIX and PROCLEIX ULTRIO blood screening assays. Gen-Probe believes that Novartis has sufficient inventory at other locations to prevent any significant disruption in supply to Novartis’ customers. The Company also said it does not expect to incur any charges in connection with this event and believes that Novartis may replace the majority of the affected products with replacement products that will be ordered during the remainder of 2008.
Gen-Probe is lucky that this is being considered an issue of storage by Novartis rather than another issue. Product recalls in the medical field are generally not received with much warmth.
Jon C. Ogg
August 18, 2008