FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Reported: October 30, 2013 Initiated: August 20, 2013 #Z-0032-2014
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.
Details
- Recalling Firm
- Bio-Rad Laboratories
- Units Affected
- 23 kits
- Distribution
- US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.. Recalled by Bio-Rad Laboratories. Units affected: 23 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2013. Severity: Low. Recall number: Z-0032-2014.
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