Wondfo USA Co Ltd: Medical Device Recall in 2024 - (Recall #: Z-2033-2024)

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:

Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC

Product Classification:

Class II

Date Initiated: April 22, 2024

Date Posted: June 19, 2024

Recall Number: Z-2033-2024

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: 102,500 units

Code Information:

Lot Numbers: W039301002, W039306002, W039312001, W03920403, W03920708, W03921003, W03921007

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated