Z-0284-2019 Class III Terminated
FDA device recall Z-0284-2019 was initiated by Acumedia Manufacturers, Inc. on August 2, 2018 and is designated Class III. Reason for recall: The product is labeled with an incorrect expiration date. The recall status is terminated (terminated January 13, 2021). Affected quantity: 93 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- August 2, 2018
- Termination Date
- January 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 93 bottles
Product Description
Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Reason for Recall
The product is labeled with an incorrect expiration date.
Distribution Pattern
US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.
Code Information
lot #110685B