Diagnostica Stago, Inc. — Class II: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitativ
Diagnostica Stago, Inc. initiated a Class II recall for STA Staclot Protein S (Lot 273074) due to a positive drift in quality control values. This issue occurs within the reagent's stated four-hour onboard stability period during qualitative and quantitative factor deficiency testing.
This recall affects clinical laboratories utilizing the STA Staclot Protein S assay, specifically those using reagent lot 273074, and personnel responsible for coagulation testing and quality control monitoring.
Positive drift in QC values suggests that results may become increasingly inaccurate as the reagent remains onboard the analyzer, potentially leading to incorrect assessments of Protein S levels. From a regulatory perspective, this indicates a failure of the product to maintain its labeled performance specifications throughout its validated stability window, necessitating a field correction and likely a review of the manufacturing or formulation process for this specific lot.
Laboratories should immediately identify and sequester reagent lot 273074. Quality assurance teams should review recent Protein S test results for potential inaccuracies linked to QC drift and ensure that current onboard stability protocols reflect the risks identified in this recall.
Class II. Reason: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified. Product: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test. Firm: Diagnostica Stago, Inc. (Parsippany NJ United States). Status: Ongoing.
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