Device product
Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Z-2212-2017
Product summary
- Event
- Event 77281
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10 units
- Official record key
device-enforcement:Z-2212-2017
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 91081C, Lot 108367A PN 91081C, Lot 107632A
Distribution pattern: US in the state of IL
Derived failure modes
-
Labeling or packaging
label was incorrect