Recall Z-0032-2014— Bio-Rad Laboratories
Class III · Terminated
Class III FDA medical device recall by Bio-Rad Laboratories, initiated 2013-08-20, terminated 2013-11-13. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Bio-Rad Laboratories
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-08-20
- Terminated
- 2013-11-13
- Firm location
- Redmond, WA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.