FDAClass IIJune 19, 2024

Independent Medical Co-op Inc recall

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…

Why was Independent Medical Co-op Inc 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?

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

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…
Recalling firm
Wondfo USA Co Ltd
Quantity
102,500 units
Distribution
US Nationwide distribution.
Recall date
June 19, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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