STA SYSTEM CONROL N + P — Class II medical device recall Z-0738-2020
Terminated recall by Diagnostica Stago, Inc., reported 2020-01-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - De
| Recall number | Z-0738-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2019-11-18 |
| Classified | 2019-12-23 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2023-01-12 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI |
| Quantity | 5,437 |
| UPC / GTIN / UDI-DI | 03607450006780 |
| Lot numbers | 253145, 253416, 253655, 254040, 254206, 254401, 254573, 254760 |
| Model numbers | 00678 |
Product
STA SYSTEM CONROL N + P (ref. 00678)
Reason for recall
A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
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-0738-2020. 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.