Diagnostica Stago, Inc.
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A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →