BinaxNOW Strep A Test (Cypress) – Licensing Shipment Error (2024)
Shipping error involves minor regulatory compliance issue for medical devices.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Brand
Cypress Medical Products LLC
Lot Codes / Batch Numbers
GTIN: 10811877010453, All Lots
Products Sold
GTIN: 10811877010453; All Lots
Cypress Medical Products LLC is recalling BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 due to Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite lice. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An URGENT PRODUCT RECALL notification letter dated 8/19/24 was sent to customers. Actions to be taken by the customer 1. Immediately examine your inventory and quarantine all product subject to this urgent product recall detailed in the affected products table above. 2. Please complete, sign, and return the enclosed response form (Attachment #1 Customer Response Form) as soon as possible, even if you do not have any product on hand. Return completed signed form to MMSQRCProductReviews@McKesson.com. 3. Destroy any affected product and complete the attached customer response form (Attachment #1 Costumer Response Form). If you have any questions, you can call directly by phone at (800) 688-8840. Representatives are available Monday Friday, 8:00 am 5:00 pm. 4. If you have further distributed this product, please notify them immediately of this urgent product recall. You are encouraged to include a copy of this notification letter in your communication. If you have questions regarding this notification, please contact McKesson Medical- Surgical directly by phone at (800) 688-8840. Representatives are available Monday Friday, 8:00 am 5:00 pm.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026