Device product
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Z-2221-2017
Product summary
- Event
- Event 77276
- Status
- Terminated
- Classification
- Class III
- Quantity
- 28 units
- Official record key
device-enforcement:Z-2221-2017
Official wording
Reason: Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Code information: PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
Distribution pattern: Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
Derived failure modes
-
Labeling or packaging
label was incorrect