FSE Image Upgrade Kit — Class III medical device recall Z-0032-2014
Terminated recall by Bio-Rad Laboratories, reported 2013-10-30, distributed in FL, IA, ME, MO, MS, NE, NY, TN…. The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS
| Recall number | Z-0032-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Rad Laboratories, Redmond, WA, United States |
| Recall initiated | 2013-08-20 |
| Classified | 2013-10-21 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-11-13 |
| Distributed | FL, IA, ME, MO, MS, NE, NY, TN, TX, WA |
| Quantity | 23 kits |
| Lot numbers | 122822 |
| Model numbers | 92019C |
Product
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Reason for recall
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.
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-0032-2014. 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.