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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.

FDA Recall Z-0542-05 · Posted 2005-02-15

Recalling FirmUps Supply Chain Solutions
Recall StatusTerminated
Date Initiated2005-02-04
Date Terminated2005-07-27
Product Quantity75 kits

Reason for Recall

The kits are not approved for use in the United States.

Firm 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'.

Root Cause

Other

Distribution Pattern

Consumers throughout the United States.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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