STA — Class II medical device recall Z-1069-2018
Terminated recall by Diagnostica Stago, Inc., reported 2018-03-21. Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
| Recall number | Z-1069-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2017-10-25 |
| Classified | 2018-03-15 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2020-05-12 |
| Lot numbers | 250041RX, 250077, 250246RU, 251308, 251492, 251626, 251730, 251772 |
| Model numbers | 00606 |
Product
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
Reason for recall
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1069-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.