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Class 3 Device Recall Image Upgrade Kit, Catalog 92019C |
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Date Initiated by Firm |
August 20, 2013 |
Date Posted |
October 21, 2013 |
Recall Status1 |
Terminated 3 on November 13, 2013 |
Recall Number |
Z-0032-2014 |
Recall Event ID |
66293 |
PMA Number |
P050048S004 |
Product Classification |
Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
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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 WA 98052-5039
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For Additional Information Contact |
Cindi Jinneman 800-224-6723
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LOM and Original Applicant = BIO-RAD LABORATORIES
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