Wondfo USA Co Ltd: Medical Device Recall in 2024 - (Recall #: Z-2031-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V

Product Classification:

Class II

Date Initiated: April 22, 2024

Date Posted: June 19, 2024

Recall Number: Z-2031-2024

Event ID: 94261

Reason for Recall:

Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distribution of this test for at-home use, non-prescription use, over-the-counter use, or direct-to-consumer customers.

Status: Ongoing

Product Quantity: 170,000 units

Code Information:

a) CD-STP25, Lot Numbers: W03920402, W03920603, W03920707, W03921002, W03921006, W039301001, W039302001, W039302003, W039306003; b) CD-STP25V, Lot Numbers: CD-STP25V W03920404, W039302002

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated