Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
FDA device recall Z-2337-2025 · posted 2025-08-18 · Open, Classified
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Reason for recall
- Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- Action taken
- McKesson notified consignees on about 07/30/2025 via overnight mail. Consignees were instructed to immediately examine inventory and quarantine all affected units, complete and return the provided response form, and destroy any affected products. If affected product was further distributed, consignees were instructed to notify their customers.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- GTY
- Quantity affected
- 5 kits
- Distribution
- US Nationwide distribution in the state of Georgia.
- Date initiated
- 2025-07-30
- Date posted
- 2025-08-18
- Location
- Richmond, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACON STREP A RAPID TEST STRIP (K010582) | Acon Laboratories Co. | 2001-05-07 |