Recall Z-3184-2024 ยท GTZ Antisera, All Groups, Streptococcus Spp.
Cypress Medical Products LLC
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
| Date | Sep 19, 2024 (initiated Aug 20, 2024) |
| Status | Open, Classified |
| 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 |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST Binax, Inc., Nov 30, 2001 |