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Open, Classified

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

FDA Recall Z-2337-2025 · Posted 2025-08-18

Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Recall StatusOpen, Classified
Product CodeGTY
Date Initiated2025-07-30
Product Quantity5 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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of Georgia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010582ACON STREP A RAPID TEST STRIPAcon Laboratories Co. · 2001-05-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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