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Class 3 Device Recall |
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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
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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
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For Additional Information Contact |
DiaSorin Technical Service 800-328-1482
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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.
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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
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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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