FDA Device recall Z-3047-2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074 by Diagnostica Stago, citing A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3047-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-29 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
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
Identifiers
| code_info | UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-10-22 · Diagnostica Stago - STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Sat…
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3047-2026%22
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