FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
FDA Recall Z-0032-2014 · Posted 2013-10-21
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Recalling FirmBio-Rad Laboratories
Recall StatusTerminated
Product CodeLOM
Date Initiated2013-08-20
Date Terminated2013-11-13
Product Quantity23 kits
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.
Firm 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.
Root Cause
Software change control
Distribution Pattern
US Distribution including the states of FL, IA, ME, MO, MS, NE, NY, TN, TX, and WA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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