FDA recall, , Moderate risk
STA Staclot Protein S
STA Staclot Protein S has a positive drift in QC values within its stated 4-hour onboard stability period.
Summary by Recall Canary from the FDA notice
What happened
Diagnostica Stago, Inc., of Parsippany, New Jersey, recalled STA Staclot Protein S, a qualitative and quantitative factor deficiency test, after a positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified. The recall began July 29, 2026, and was added to the FDA's Enforcement Report on August 28, 2026. The product was distributed nationwide in the states and territory of NJ, NY, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, and PR.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
STA Staclot Protein S
- UDI-DI
- 3607450007466
- Lot code
- 273074
From the FDA notice
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
Recall details
- Company began the recall
- Sold in
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.
- Company
- Diagnostica Stago, Inc.Parsippany, New Jersey
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99531
- Recall number
- Z-3047-2026
- Quantity recalled
- 5220 units
All recalls from Diagnostica Stago, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
