The FDA has classified a recall of Diagnostica Stago's STA Liatest Free Protein S kits as Class II, indicating that use of or exposure to a defective product may cause adverse health consequences that are temporary or medically reversible. The specific issue identified is the potential for out-of-range results and an underestimation of the free protein S level in normal patient plasmas, affecting only normal-range values. The recall has worldwide distribution, including extensive nationwide distribution within the United States across multiple states.

Healthcare providers and medical device distributors who have these kits should be aware of the recall and its implications for patient diagnosis. While the adverse health consequences are noted as potentially temporary or medically reversible, the accuracy of diagnostic results is critical. Compliance officers should review their inventory and patient records to identify affected kits and ensure appropriate actions are taken according to FDA guidelines and internal protocols. The ongoing nature of the recall suggests that affected parties should be prepared for potential follow-up actions or inquiries from the FDA.