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Class 3 Device Recall TrepChek Syphilis Test Kit |
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Date Initiated by Firm |
March 16, 2005 |
Date Posted |
April 28, 2005 |
Recall Status1 |
Terminated 3 on July 22, 2006 |
Recall Number |
Z-0784-05 |
Recall Event ID |
31710 |
510(K)Number |
K001552
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Product Classification |
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
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Product |
Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2. |
Code Information |
lot # 041207T expiration date 9-30-2005 |
Recalling Firm/ Manufacturer |
Diasorin Inc. 1951 Northwestern Ave S Stillwater MN 55082-7536
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Manufacturer Reason for Recall |
Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
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FDA Determined Cause 2 |
Other |
Action |
Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers. |
Quantity in Commerce |
14 kits |
Distribution |
MA, CA, TX, KS, NY, FL |
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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510(K) Database |
510(K)s with Product Code = LIP and Original Applicant = PHOENIX BIOTECH CORP.
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