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 | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| Product | Staclot® LA (REF 00600) The Staclot® LA and Staclot® LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2). |
| Quantity | 22342 total |
| Distribution | US Nationwide Distribution |
| Initiated | 2018-11-14 |
| Classified | 2018-12-14 |
| Terminated | 2020-06-08 |
| Recall number | Z-0610-2019 |
| 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-0610-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81678/
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