Z-2337-2025Class II

Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020

Name: Z-2337-2025 Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2025-07-30
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2025-07-30 / Open, Classified / root cause: manufacturing process

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a recall of Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020 on 2025-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2337-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-30
Posted: 2025-08-18
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Product: Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
Product code: GTY Antigens, All Groups, Streptococcus Spp.
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 5 kits
Distribution: US Nationwide distribution in the state of Georgia.
Product codes and lots: Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2337-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2337-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-18

Product code GTY

K010582Class IAcon Strep a Rapid Test StripAcon Laboratories Co. / cleared 2001-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)