FDA Device recall Z-2337-2025
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived
- FDA Device
- Class II
- ongoing
- Published 2025-08-27
On 2025-08-27 the FDA classified a Class II recall of Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived by Mckesson Medical Surgical Corporate Office, citing 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 devic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2337-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-30 |
| Published | 2025-08-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
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.
Identifiers
| code_info | Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Drug · Class II · 2025-07-30 · Mckesson Medical Surgical Corporate Office - BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA
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All Mckesson Medical Surgical Corporate Office recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2337-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.