EVOLIS Microplate System — Class II medical device recall Z-0807-2016
Terminated recall by Bio-Rad Laboratories, Inc., reported 2016-02-24, distributed nationwide. The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawe
| Recall number | Z-0807-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Inc., Redmond, WA, United States |
| Recall initiated | 2015-12-22 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 278 units |
| Serial numbers | 9163700126, 9163700168R, 9163700172R, 9163700175, 9163700176R, 9163700187, 9163700196, 9163700202R, 9163700206R, 9163700208, 9163700209R, 9163700210, 9163700215R, 9163700221R, 9163700231, 9163700234R, 9163700236R, 9163700242R, 9163700246R, 9163700247R, 9163700266, 9163700276R, 9163700278, 9163700281R, 9163700282R and 253 more |
| Model numbers | 89601, 89788 |
Product
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
Reason for recall
The error "Washer Reagent Clean Fluid" level low alarmed, which prompted the customer to open the system drawer. When the system drawer was opened the customer noted the plate transport was still running and as a consequence the plate was pushed off the plate transporter.
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-0807-2016. 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.