BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025

FDA device recall Z-3184-2024 · posted 2024-09-19 · Open, Classified

Recall details

Recalling firm

Cypress Medical Products LLC

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

GTZ

Quantity affected

15 kits

Distribution

US Nationwide distribution.

Date initiated

2024-08-20

Date posted

2024-09-19

Location

Richmond, VA

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