Class 2 Device Recall

• Date Initiated by Firm: February 04, 2005
• Date Posted: February 15, 2005
• Recall Status: Terminated 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: 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.