BinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers
Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall driven by regulatory non-compliance (unlicensed distribution) rather than a product defect. No illnesses, injuries, or hospitalizations have been reported. The hazard of improper use by unlicensed personnel is entirely theoretical.
Plain-English summary
Cypress Medical Products LLC is recalling BinaxNOW Respiratory Strep A Test Kits (Catalog Number 730025, GTIN 10811877010453) due to a classification error in the manufacturer's inventory management system. All lots of the product were incorrectly shipped to customers who did not have the requisite license to purchase these medical devices.
The affected products were distributed nationwide throughout the United States. No illnesses or injuries have been reported in connection with this recall.
Customers who received these kits without proper licensing should contact Cypress Medical Products LLC for further instructions. Appropriately licensed healthcare providers and facilities should verify that their licensing permits them to use this product.
The recalled product
- Product
- BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device
- Hazard
- Affected units
- 15
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: 10811877010453
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cypress Medical Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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