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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm February 04, 2005
Date Posted February 15, 2005
Recall Status1 Terminated 3 on July 27, 2005
Recall Number Z-0542-05
Recall Event ID 31097
Product RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging.
Code Information All lots are subject to recall.
Recalling Firm/
Manufacturer		 Ups Supply Chain Solutions
12380 Morris Rd
Alpharetta GA 30005-4177
For Additional Information Contact Customer Service Representative
866-706-8780
Manufacturer Reason
for Recall		 The kits are not approved for use in the United States.
FDA Determined
Cause 2		 Other
Action Letters dated February 4, 2005, flagged 'Important Safety Notice -- Test Kit Recall' with instructions to consumers to destroy kits and to consult a health care professional if they have used the test kit. Letters will require a signed receipt. Letterhead used identifies recalling firm as 'FDTS'.
Quantity in Commerce 75 kits
Distribution Consumers throughout the United States.
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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