FDA Device recall Z-0252-2013
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the perfor…
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the perfor… by Diagnostica Stago, citing following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0252-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-06-15 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Reason
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
Identifiers
| code_info | K082248 D089976 Ref 58104 units |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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FDA Device · Class II · 2026-03-25 · Diagnostica Stago - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
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FDA Device · Class II · 2026-01-21 · Diagnostica Stago - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0252-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.