FSE Image Upgrade Kit recall
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Why was FSE Image Upgrade Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 122822
- Product
- FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
- Recalling firm
- Bio-Rad Laboratories
- Quantity
- 23 kits
- Distribution
- US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
- Recall date
- October 30, 2013
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)