Recall Z-0807-2016— Bio-Rad Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2015-12-22, terminated 2017-03-13. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-22
- Terminated
- 2017-03-13
- Firm location
- Redmond, WA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.