Skip to content
Recall Observatory FDA recall evidence

Device product

Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008

Z-3185-2024

August 20, 2024

Class II

Product summary

Firm
Cypress Medical Products LLC
Event
Event 95235
Status
Ongoing
Classification
Class II
Quantity
5 kits
Official record key
device-enforcement:Z-3185-2024

Official wording

Reason: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Code information: GTIN: 10815845020031; All Lots

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.