DELFIA¿ PC with V3 — Class III medical device recall Z-1102-2017
Terminated recall by PerkinElmer Health Sciences, Inc., reported 2017-02-01, distributed nationwide. AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
| Recall number | Z-1102-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PerkinElmer Health Sciences, Inc., Waltham, MA, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-01-26 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-10-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, ES, FR, GB, IL, IN, KR, MA, PH, TW, VN |
| Reason classes | software |
| Lot numbers | 18RXWD2, 18TYWD2, 18WYWD2, B901XD2 |
Product
DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number: 1235-8100 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven and widely used method of time resolved fluorometry
Reason for recall
AutoDELFIA System with Version 3.0 Software: Potential plate loading failures
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-1102-2017. 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.