FDA Device recall Z-0387-2018
Phadia 1000 Instrument, Article Number 12-3800-01
- FDA Device
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Phadia 1000 Instrument, Article Number 12-3800-01 by Phadia Us, citing the "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0387-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-05 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Phadia Us |
| Distribution | US |
Product
Phadia 1000 Instrument, Article Number 12-3800-01.
Reason
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Identifiers
| code_info | All versions of the instrument |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0387-2018%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.