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 | QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %) |
| Product | Diagnostica Stago STA Noplastine® CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. REF: 00666 The STA® - Noplastine® CI kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R®, STA Compact® and STA Satellite®. (In the USA this procedure has been assigned to the moderate complexity category per CLIA 1988 - CDC Analyte Code 4922; CDC Test System Codes 4677 and 4875). |
| Quantity | 5 kits |
| Distribution | Nationwide |
| Initiated | 2018-07-24 |
| Classified | 2018-09-07 |
| Terminated | 2020-05-18 |
| Recall number | Z-2994-2018 |
| 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-2994-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80826/
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