FDAClass IISeptember 25, 2024

Acceava Respiratory Strep A recall

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Why was Acceava Respiratory Strep A recalled?

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

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?

GTIN: 10815845020031; All Lots

Product
Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
Recalling firm
Cypress Medical Products LLC
Quantity
5 kits
Distribution
US Nationwide distribution.
Recall date
September 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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