Clearview Strep A Exact II Diagnostic Kit Distributed to Unlicensed Facilities
Due to an inventory system error, Clearview Strep A Exact II diagnostic kits were shipped to facilities without the required license to purchase them.
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: FDA Class II recall due to distribution error, with no reported illnesses, injuries, or hospitalizations. The product itself is not defective; the hazard is potential misuse by unqualified personnel due to regulatory non-compliance in the distribution process.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling all lot numbers of the Clearview Strep A Exact II Dipstick Respiratory Kit (Catalog Number 4581225020). This is a CLIA-waived diagnostic test used for detecting Group A Streptococcus.
Due to a classification error in the inventory management system, these devices were shipped to customers that did not have the requisite license or credentials to purchase and use them. The product was distributed in Georgia.
Customers who received this device should verify they have the appropriate licensing and credentials to use it. If you are unsure about your license status or believe you received this device in error, do not use it and contact Mckesson Medical-Surgical Inc. immediately.
For more information about this recall, contact Mckesson Medical-Surgical Inc. or the FDA.
The recalled product
- Product
- Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived. Catalog Number: 4581225020
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-use
- diagnostic-error
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
Distributed nationwide across the United States.
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