FDA Medical Device Recalls (openFDA)
Mckesson Medical-Surgical Inc. Corporate Office: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Recall number
- Z-2337-2025
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Status
- Open, Classified
- Initiated
- 2025-07-30
- Posted
- 2025-08-18
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
- 510(k) numbers
- ["K010582"]
- PMA numbers
- not on file
- Product code
- GTY
- Firm FEI
- 3004386693
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28