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Recall Observatory FDA recall evidence

Device product

Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A Swab Test and EASY at Home Medical LLC, Areta One Step Strep A Swab Test, Part Number ARST-100

Z-2032-2024

April 22, 2024

Class II

Product summary

Firm
Wondfo USA Co Ltd
Event
Event 94261
Status
Ongoing
Classification
Class II
Quantity
75,000 units
Official record key
device-enforcement:Z-2032-2024

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: E03920802

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.