Phadia 1000 Instrument — Class II medical device recall Z-0387-2018
Terminated recall by Phadia US Inc, reported 2018-01-24, distributed nationwide. The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and aff
| Recall number | Z-0387-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Phadia US Inc, Portage, MI, United States |
| Recall initiated | 2017-07-05 |
| Classified | 2018-01-18 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-10-04 |
| Distributed | Nationwide (US) |
| Quantity | 70 units |
| Reason classes | potency |
Product
Phadia 1000 Instrument, Article Number 12-3800-01.
Reason for recall
The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test 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-0387-2018. 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.