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Recall Observatory FDA recall evidence

Device product

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

Z-2033-2024

April 22, 2024

Class II

Product summary

Firm
Wondfo USA Co Ltd
Event
Event 94261
Status
Ongoing
Classification
Class II
Quantity
102,500 units
Official record key
device-enforcement:Z-2033-2024

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

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.