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U.S. Department of Health and Human Services

Class 2 Device Recall TREPCHEK

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  Class 2 Device Recall TREPCHEK see related information
Date Initiated by Firm December 09, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 20, 2008
Recall Number Z-0513-04
Recall Event ID 28083
510(K)Number K001552  
Product Classification Enzyme Linked Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
Product Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
Code Information Lot Number 71303, expiration date June 2004
Recalling Firm/
Manufacturer		 Diamedix Corporation
2140 N Miami Ave
Miami FL 33127-4916
For Additional Information Contact Dr. Lynne Stirling
800-324-2300
Manufacturer Reason
for Recall		 The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
FDA Determined
Cause 2		 Other
Action A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.
Quantity in Commerce 8
Distribution Product was distributed to three hospitals/clinics in AZ, CA and TX.
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 = LIP and Original Applicant = PHOENIX BIOTECH CORP.
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