FDA Medical devices recall ·
STA Staclot Protein S, Model recall
- Recall number
- Z-3047-2026
- Date
- (initiated July 29, 2026)
- Company / brand
- Diagnostica Stago, Inc.
5 Century Dr, Parsippany, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 5220 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Why was it recalled?
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
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.
States: Alabama California Colorado Florida Georgia Illinois Missouri Nebraska New Jersey New York Ohio Pennsylvania Puerto Rico Tennessee Texas Utah Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3047-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.