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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm March 09, 2004
Date Posted October 01, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-1576-05
Recall Event ID 32608
Product Classification Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus - Product Code MZO
Product ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
Code Information version 12 and older software
Recalling Firm/
Manufacturer
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Service
800-328-1482
Manufacturer Reason
for Recall
An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
FDA Determined
Cause 2
Other
Action Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.
Quantity in Commerce 128
Distribution AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
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.
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