Z-0032-2014Class III

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

Name: Z-0032-2014 FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the...
Creator: Bio-Rad Laboratories
Published: 2013-08-20
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2013-08-20 / Terminated / root cause: software

FDA source

Bio-Rad Laboratories began a recall of FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System on 2013-08-20. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0032-2014
Classification: Class III
Status: Terminated
Initiated: 2013-08-20
Posted: 2013-10-21
Terminated: 2013-11-13
Recalling firm: Bio-Rad Laboratories Inc.
Product: FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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.
Root cause tag: software
FDA root cause: Software change control
Action: BioRad has sent an Urgent Product Correction letter dated August 19, 2013, to customers who had the EVOLIS FSE Upgrade Image Kit installed on the EVOLIS at their site by a Bio-Rad Laboratories Field Service Engineer (FSE). This issue impacts laboratory only if you are running the MONOLISA Anti-HBs EIA Quantitative Determination method with EVOLIS APF version 6.0 and TimeLiner Data Management Software. If you use this Quantitative Determination method with EVOLIS APF version 6.0, please contact Bio-Rad Laboratories for additional information or assistance. Bio-Rad Laboratories is currently developing and qualifying a software update CD consisting of the EVOLIS APF V6.0b and Timeliner Data Management Software to correct the issue. The software update CD will be installed by Bio-Rad Field Service Engineers at each of the customer sites when installing the EVOLIS APF V6.0b. Customers should contact Bio-Rad Laboratories at 1-800-224-6723, Option 2 and then Option 3 for any questions about this product correction.
Quantity in commerce: 23 kits
Distribution: US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
Product codes and lots: Lot 122822

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0032-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0032-2014	Class III	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-21

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)