Class II — Diagnostica Stago, Inc.
| Recalling firm | Diagnostica Stago, Inc. |
|---|---|
| Registered facility | DIAGNOSTICA STAGO, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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®. |
| 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. |
| Quantity | 232 units US; 5 units Canada |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
| Initiated | 2012-06-15 |
| Classified | 2012-11-06 |
| Terminated | 2013-07-19 |
| Recall number | Z-0252-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diagnostica Stago, Inc. (Z-0252-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63270/
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