Diagnostica Stago, Inc. recalls STA Staclot Protein S
- Recalling company
- Diagnostica Stago, Inc.
- Product
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 29, 2026
- Reported
- Sep 9, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 5220 units
- Lot / codes
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
- Company location
- Parsippany, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3047-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3047-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.