Z-2221-2017 Class III Terminated
FDA device recall Z-2221-2017 was initiated by Acumedia Manufacturers, Inc. on September 25, 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: 28 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- September 25, 2016
- Termination Date
- June 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28 units
Product Description
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
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
Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
Code Information
PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C