Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

FSE Image Upgrade Kit Recalled by Bio-Rad Laboratories Due to The FSE Image Upgrade kit (part 92019C) is...

Date: August 20, 2013
Company: Bio-Rad Laboratories
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Rad Laboratories directly.

Affected Products

FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

Quantity: 23 kits

Why Was This 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.

Where Was This Sold?

This product was distributed to 10 states: FL, IA, ME, MS, MO, NE, NY, TN, TX, WA

Affected (10 states)Not affected

About Bio-Rad Laboratories

Bio-Rad Laboratories has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report