Z-3047-2026 Class II Ongoing
FDA device recall Z-3047-2026 was initiated by Diagnostica Stago, Inc. on July 29, 2026 and is designated Class II. Reason for recall: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified The recall status is ongoing. Affected quantity: 5220 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5220 units
Product Description
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
Distribution Pattern
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.
Code Information
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027