STA Satellite Automated Multi-Parameter Analyzer This system is a… — Class II medical device recall Z-0252-2013
Terminated recall by Diagnostica Stago, Inc., reported 2012-11-14, distributed nationwide. Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even t
| Recall number | Z-0252-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2012-06-15 |
| Classified | 2012-11-06 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Model numbers | 58104 |
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 for recall
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¿.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0252-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.