BinaxNOW Respiratory Strep A Test Kit recall
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Why was BinaxNOW Respiratory Strep A Test Kit 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: 10811877010453; All Lots
- Product
- BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- Recalling firm
- Cypress Medical Products LLC
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution.
- Recall date
- September 25, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)