FDA Enforcement
Class III
Terminated
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.
Recall: Z-0284-2019
·
Reported November 7, 2018
Enforcement
- Recall Number
- Z-0284-2019
- Event ID
- 81107
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Acumedia Manufacturers, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 7, 2018
- Initiation Date
- August 2, 2018
- Classification Date
- October 26, 2018
- Termination Date
- January 13, 2021
- Address
- 740 E Shiawassee St, N/A, Lansing, MI, 48912-1218, United States
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
The product is labeled with an incorrect expiration date.
Code Info
lot #110685B
Distribution
US Distribution to states of: FL, TN; and internationally to countries of: Brazil, and Canada.
Quantity
93 bottles