Recall Z-2337-2025 ยท GTY Antigens, All Groups, Streptococcus Spp.
Mckesson Medical-Surgical Inc. Corporate Office
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
| Date | Aug 18, 2025 (initiated Jul 30, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 5 kits |
| Distribution | US Nationwide distribution in the state of Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010582 | ACON STREP A RAPID TEST STRIP Acon Laboratories Co., May 7, 2001 |