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Recall Observatory FDA recall evidence

Device product

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

Z-2030-2024

April 22, 2024

Class II

Product summary

Firm
Wondfo USA Co Ltd
Event
Event 94261
Status
Ongoing
Classification
Class II
Quantity
1,238,755 units
Official record key
device-enforcement:Z-2030-2024

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.