Bio-Rad Laboratories: Medical Device Recall in 2013 - (Recall #: Z-0032-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: August 20, 2013

Date Posted: October 30, 2013

Recall Number: Z-0032-2014

Event ID: 66293

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.

Status: Terminated

Product Quantity: 23 kits

Code Information:

Lot 122822

Distribution Pattern:

US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA

Voluntary or Mandated:

Voluntary: Firm initiated