Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Summary
The FDA issued a Class II for Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number by Mckesson Medical-Surgical Inc. Corporate Office. Reason: Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite l.
Details
Source
Device Recall
External ID
Z-2337-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
Product Description
Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Lot/Code Info: Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Quantity Affected: 5 kits
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.
Distribution
US Nationwide distribution in the state of Georgia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-30
Company
Richmond, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2337-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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