STA Staclot Protein S recall (Diagnostica Stago, Inc.)
Medical deviceClass IIOngoing
Summary: Diagnostica Stago, Inc. is recalling 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.
What is being recalled
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Why
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Alabama, California, Colorado, Florida, Georgia, Illinois, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia)
How to tell if yours is affected
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3047-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 29, 2026 |
| Reported | September 9, 2026 |
| Company | Diagnostica Stago, Inc. |
| Company location | Parsippany, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5220 units |
More recalls from Diagnostica Stago, Inc. · all medical device recalls · recalls from July 2026