FDA Recall
Terminated
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.
Recall: Z-0542-05
·
Initiated February 4, 2005
Recall
- Recall Number
- Z-0542-05
- Event Number
- 31097
- Firm
- Ups Supply Chain Solutions
- FEI Number
- 3004071323
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 4, 2005
- Posted
- February 15, 2005
- Terminated
- July 27, 2005
- Address
- 12380 Morris Rd, Alpharetta, GA, 30005-4177
Description
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.
Reason
The kits are not approved for use in the United States.
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'.
Distribution
Consumers throughout the United States.
Quantity
75 kits