Device recall
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Recall number
- Z-3047-2026
- Event id
- 99531
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Diagnostica Stago, Inc.
- Report date
- Sep 9, 2026
- Posted
- Aug 28, 2026
- Initiated
- Jul 29, 2026
- Center classification date
- Aug 28, 2026
- Product code
- GGP
- Device type
- Test, Qualitative And Quantitative Factor Deficiency
- Reason
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Root cause
- Under Investigation by firm
- Quantity
- 5220 units
- Code info
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K913424
- Location
- Parsippany, NJ, United States