Recall Z-0807-2016 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Bio-Rad Laboratories, Inc.
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.
| Date | Feb 13, 2016 (initiated Dec 22, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | Bio-Rad sent an Urgent Product Notification letter, dated December 22, 2015, to consignees via Fed-Ex. The firm recognized the typographical error of the PN number on the first letter and sent a revised notification letter, dated 20 January 2016, with the correct PN 89788 to consignees. The letter identified the affected product, problem and actions to be taken. Consignees are advised that in addition to the WARNING in Chapter 4.9.2 in the EVOLIS Operators Manual (PN 89788) mention is made of, "LED lamps on the front panel of the EVOLIS instrument illuminate when a compartment may be acce |
| Quantity | 278 units |
| Distribution | US Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.