Class II

Medical Device Recall: 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

Wondfo USA Co Ltd · April 22, 2024

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

102,500 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2033-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.