FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- Recall number
- Z-3184-2024
- Recalling firm
- Cypress Medical Products LLC
- Product
- BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
- Status
- Open, Classified
- Initiated
- 2024-08-20
- Posted
- 2024-09-19
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 15 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- GTIN: 10811877010453; All Lots
- 510(k) numbers
- ["K012521"]
- PMA numbers
- not on file
- Product code
- GTZ
- Firm FEI
- 1451040
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28