FDA Device recall Z-0807-2016
EVOLIS Microplate System, Catalog # 89601
- FDA Device
- Class II
- terminated
- Published 2016-02-24
On 2016-02-24 the FDA classified a Class II recall of EVOLIS Microplate System, Catalog # 89601 by Bio Rad Laboratories, citing 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 tra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0807-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-22 |
| Published | 2016-02-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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.
Identifiers
| code_info | The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is ass…The EVOLIS Microplate System instrument is not lot controlled, however for traceability purposes each instrument is assigned a unique serial number. SERIAL NUMBERS: 9163700126, 9163700175, 9163700187, 9163700196, 9163700208, 9163700210, 9163700231, 9163700266, 9163700278, 9163700320, 9163700328, 9163700336, 9163700337, 9163700349, 9163700354, 9163700368, 9163700402, 9163700431, 9163700449, 9163700478, 9163700480, 9163700481, 9163700495, 9163700498, 9163700499, 9163700501, 9163700510, 9163700527, 9163700530, 9163700531, 9163700544, 9163700556, 9163700558, 9163700559, 9163700560, 9163700567, 9163700585, 9163700587, 9163700594, 9163700595, 9163700623, 9163700624, 9163700625, 9163700629, 9163700656, 9163700695, 9163700696, 9163700722, 9163700743, 9163700744, 9163700745, 9163700764, 9163700765, 9163700772, 9163700775, 9163700776, 9163700810, 9163700821, 9163700822, 9163700823, 9163700835, 9163700836, 9163700843, 9163700844, 9163700846, 9163700850, 9163700851, 9163700853, 9163700855, 9 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0807-2016%22
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