BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Recall
- Recall Number
- Z-3184-2024
- Event Number
- 95235
- Firm
- Cypress Medical Products LLC
- FEI Number
- 1451040
- Product Code
- GTZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- August 20, 2024
- Posted
- September 19, 2024
- Address
- 9954 Mayland Dr, Richmond, VA, 23233-1464
Description
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
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.
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 [email protected]. 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.
US Nationwide distribution.
15 kits