FDA Device recall Z-0032-2014
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System
- FDA Device
- Class III
- terminated
- Published 2013-10-30
On 2013-10-30 the FDA classified a Class III recall of FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System by Bio Rad Laboratories, citing the FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONO….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0032-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-08-20 |
| Published | 2013-10-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bio Rad Laboratories |
| Distribution | FL, IA, ME, MO, MS, NE, NY, TN, TX, WA |
Product
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Reason
The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.
Identifiers
| code_info | Lot 122822 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0032-2014%22
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