Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA… recallZ-2337-2025 · Mckesson Medical-Surgical Inc. Corporate Office · initiated Jul 30, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mckesson Medical-Surgical Inc. Corporate Office or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2337-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 30, 2025
- Posted by the FDA
- Aug 18, 2025
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 5 kits
- Product code
- GTY
- FDA submissions
- K010582
- Distribution
- US Nationwide distribution in the state of Georgia.
Product description
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Code information (models, lots, serial numbers)
Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Clearview® 92002Alere San Diego, Inc. · Antigens, All Groups, Streptococcus Spp.1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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