FDAClass IIJune 19, 2024

Preview Strep A recall

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

Why was Preview Strep A recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Recalling firm
Wondfo USA Co Ltd
Quantity
1,238,755 units
Distribution
US Nationwide distribution.
Recall date
June 19, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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