EVOLIS Microplate System — Class II medical device recall Z-1906-2019
Ongoing recall by Bio-Rad Laboratories, Inc, reported 2019-07-10, distributed nationwide. User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testin
| Recall number | Z-1906-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc, Redmond, WA, United States |
| Recall initiated | 2019-01-10 |
| Classified | 2019-06-30 |
| Reported by FDA | 2019-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 213 devices |
| UPC / GTIN / UDI-DI | 03610520562024 |
| Model numbers | 89700, 90471A |
Product
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Reason for recall
User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
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-1906-2019. 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.