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 | Ongoing |
| Reason | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13). |
| Product | STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 |
| Quantity | 5 analyzers |
| Distribution | US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. |
| Initiated | 2023-03-22 |
| Classified | 2023-05-10 |
| Recall number | Z-1577-2023 |
| 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-1577-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92007/
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