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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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