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U.S. Department of Health and Human Services

Class 2 Device Recall EVOLIS Assay Protocol Files ( APF) Software

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  Class 2 Device Recall EVOLIS Assay Protocol Files ( APF) Software see related information
Date Initiated by Firm July 19, 2010
Date Posted May 19, 2011
Recall Status1 Terminated 3 on August 25, 2011
Recall Number Z-2201-2011
Recall Event ID 56389
510(K)Number K092353  K961053  
Product Classification Enzyme linked immunoabsorbent assay, rubella - Product Code LFX
Product Software CD is labeled in part:
"BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***"

The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data reduction and generate reports.
Code Information APF Version 4.4 Software Version 2.00 2009/05 LOT=V4.4-0505-2
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Scott Dennis
425-498-1709
Manufacturer Reason
for Recall		 The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values.
FDA Determined
Cause 2		 Software design
Action Bio-Rad Laboratories sent an Urgent Product Correction letter dated July 19, 2010, to all customer sites via FedEx. There are two issues related to The EVOLIS Assay Protocol Files (APF) Software that could potentially affect patient results. Issue 1 involves quantitative sample test/calculations/results interpretation for assays with linear regression, point to point or 4PL data reduction. Issue 2 involves sample test results with " Result Report Flags''. A software patch to correct these two issues will be sent to each customer site. Bio-Rad Laboratories will work with each customer to complete documentation confirming that the software patch has been successfully installed on each instrument. If you have any questions or concerns regarding these two issues, please contact Technical Support at 1-800-224-6723, option 2 and then option 3.
Quantity in Commerce 272
Distribution Nationwide Distribution -- Including Puerto Rico.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = LFX and Original Applicant = BIO-RAD LABORATORIES, INC.
510(K)s with Product Code = LFX and Original Applicant = QUEST INTL., INC.
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