STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Why it was recalled
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
What to do
The recall is ongoing. Follow the firm and FDA instructions.
Affected products and identifiers
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027 — 5220 units
Record details
Diagnostica Stago, Inc. — US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.