FDA recall Z-2030-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-04-22

Report date

2024-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Willowbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2030-2024