FDAFDA recall Z-3047-2026 · Sep 9, 2026
Diagnostica Stago, Inc.: STA Staclot Protein S recall
Recall found
Product
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Reason for recall
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
- Quantity
- 5220 units
- 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.
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-29
Source: openFDA enforcement record Z-3047-2026 · search recall number Z-3047-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.