Strep A test kits recalled after shipment to unlicensed purchasing customers
Clearview Strep A Exact II Dipstick Respiratory Kits are recalled because a classification error in the inventory system sent devices to customers without the required license to buy them. 5 kits are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the issue is a distribution licensing error rather than any defect in the product, and no health hazard is described.
Plain-English summary
The Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA waived, catalog number 4581225020, GTIN 10815845020024, is being recalled across all lot numbers. The recall covers 5 kits distributed in Georgia.
Because of 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. The FDA classified the action as Class II. The notice does not describe a defect in the kits themselves.
Customers who received an affected kit should follow the manufacturer's instructions for return.
The recalled product
- Product
- Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 4581225020. GTIN: 10815845020024. All lot numbers
Distribution
Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions
FDA (Devices) · 2025-06-04
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · distribution error
See all →- SevereChloraPrep One-Step Applicators Recalled for Lack of Sterile Assurance
FDA (Drugs) · 2026-07-08
- HighFrozen raw shrimp recalled after product on FDA nitrofuran hold shipped
FDA (Food) · 2025-10-08
- HighCOVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories
FDA (Devices) · 2021-09-08
- ModerateStryker Recalls Reprocessed Xcel Bladeless Trocars Due to Distribution Error
FDA (Devices) · 2018-12-05
- ModerateEthicon Recalls Evicel Fibrin Sealant Accessory Tips Due to Distribution Error
FDA (Devices) · 2018-05-02