Official recall notice
FDA DeviceClass IINotable
FDA Recall: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quan
- Recall date
- 2026-09-09
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Product description
A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Affected products
UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027