FDA Device recall Z-2397-2019
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodia…
- FDA Device
- Class II
- terminated
- Published 2019-09-04
On 2019-09-04 the FDA classified a Class II recall of Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodia… by Phadia Ab, citing code 7-102 Liquid Sensor Error.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2397-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-09 |
| Published | 2019-09-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Phadia Ab |
| Distribution | US |
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
code 7-102 Liquid Sensor Error
Identifiers
| code_info | All Serial Numbers; Unique Device Identifier (UDI): 07333066001005 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2397-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.