FDAFDA · Food and drugs·Recall number 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.
Published October 30, 2013 · Recall initiated: August 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bio-Rad Laboratories
- Distributor
- US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
- Lot
- Lot 122822
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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