FDA Enforcement
Class II
Terminated
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
Recall: Z-1444-2015
·
Reported April 22, 2015
Enforcement
- Recall Number
- Z-1444-2015
- Event ID
- 70767
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Hardy Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 22, 2015
- Initiation Date
- March 4, 2015
- Classification Date
- April 14, 2015
- Termination Date
- July 13, 2015
- Address
- 1430 W Mccoy Ln, N/A, Santa Maria, CA, 93455-1005, United States
Description
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
Reason
The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.
Code Info
Lot no. 15037, Expires: 00-00-2000
Distribution
Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
Quantity
840 (84 pk/10)