Wondfo USA Co Ltd: Medical Device Recall in 2024 - (Recall #: Z-2030-2024)

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:

Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

Product Classification:

Class II

Date Initiated: April 22, 2024

Date Posted: June 19, 2024

Recall Number: Z-2030-2024

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: 1,238,755 units

Code Information:

a) PRE-STA-25, UDI/DI **, Lot Numbers: W03921102, W039301003, W039301005, W039301004, W039309003, W039309007, W03910902, W03911002, W03910911, W03921005, W03921102, W03921008, W039212001, W039212006, W03920804; b) PRE-STA-10, UDI/DI **, Lot Numbers: W03920902, W03921103, W039307002, W039306008, W03931002

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated