Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is… — Class II medical device recall Z-2397-2019
Terminated recall by Phadia Ab, reported 2019-09-04, distributed nationwide. code 7-102 Liquid Sensor Error
| Recall number | Z-2397-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia Ab, Uppsala, N/A, Sweden |
| Recall initiated | 2019-07-09 |
| Classified | 2019-08-26 |
| Reported by FDA | 2019-09-04 |
| Terminated | 2022-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 387 instruments |
| UPC / GTIN / UDI-DI | 07333066001005 |
| Model numbers | 12-3800-01 |
Product
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
Reason for recall
code 7-102 Liquid Sensor Error
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-2397-2019. 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.