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 | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Product | STA - Neoplastine® Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT). |
| Distribution | Nationally |
| Initiated | 2017-10-25 |
| Classified | 2018-03-15 |
| Terminated | 2020-05-12 |
| Recall number | Z-1068-2018 |
| 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-1068-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79292/
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