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U.S. Department of Health and Human Services

Class 3 Device Recall Image Upgrade Kit, Catalog 92019C

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 Class 3 Recall
Image Upgrade Kit, Catalog 92019C
see related information
Date Posted October 21, 2013
Recall Status1 Terminated on November 13, 2013
Recall Number Z-0032-2014
Recall Event ID 66293
Premarket Approval
PMA Number
P050048/S004
Product Classification Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) - Product Code LOM
Product FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.
Code Information Lot 122822
Recalling Firm/
Manufacturer
Bio-Rad Laboratories
6565 185th Ave NE
Redmond, Washington 98052-5039
For Additional Information Contact Cindi Jinneman
800-224-6723
Manufacturer 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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LOM and Applicant = BIO-RAD LABORATORIES
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