Acceava Respiratory Strep A test kits recalled for unlicensed distribution
Cypress Medical Products recalls Acceava Respiratory Strep A diagnostic test kits nationwide due to a classification error that caused them to be shipped to customers without proper licensing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is distribution to unlicensed facilities, which creates a risk of improper use of a diagnostic device. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cypress Medical Products LLC is recalling Acceava Respiratory Strep A test kits (CLIA Waived, Catalog Number 4580295008) due to a classification error in the company's inventory management system. The kits were shipped nationwide to customers who did not hold the requisite licenses to purchase these devices.
The recall affects all lots of the product. Customers who have received these kits should verify that they hold the appropriate licensing required to purchase and use these devices. If you are not properly licensed, you should not use these kits.
No illnesses or injuries related to this recall have been reported. Customers with questions about the recall or their licensing status should contact Cypress Medical Products LLC.
The recalled product
- Product
- Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
- Manufacturer
- Cypress Medical Products LLC
- Category
- Medical Device — Diagnostic Test
- Hazard
- unlicensed-distribution
- improper-use
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 (2)
- GTIN: 10815845020031
- All Lots
Distribution
Distributed nationwide across the United States.
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