Recall Z-0032-2014 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Bio-Rad Laboratories
FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
| Date | Oct 21, 2013 (initiated Aug 20, 2013) |
| Status | Terminated |
| Reason | 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 | 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 de |
| Quantity | 23 kits |
| Distribution | US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.