Z-2212-2017 Class III Terminated
FDA device recall Z-2212-2017 was initiated by Acumedia Manufacturers, Inc. on August 8, 2016 and is designated Class III. Reason for recall: Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C. The recall status is terminated (terminated June 2, 2017). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- August 8, 2016
- Termination Date
- June 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
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
Reason for Recall
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Distribution Pattern
US in the state of IL
Code Information
PN 91081C, Lot 108367A PN 91081C, Lot 107632A