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Recall Observatory FDA recall evidence

Device product

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

Z-2337-2025

July 30, 2025

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 97315
Status
Ongoing
Classification
Class II
Quantity
5 kits
Official record key
device-enforcement:Z-2337-2025

Official wording

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.

Code information: Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers

Distribution pattern: US Nationwide distribution in the state of Georgia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.