Z-2192-2015 Class II Terminated
FDA device recall Z-2192-2015 was initiated by Hardy Diagnostics on June 24, 2015 and is designated Class II. Reason for recall: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. The recall status is terminated (terminated August 28, 2015). Affected quantity: 1,500.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- June 24, 2015
- Termination Date
- August 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,500
Product Description
HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening.
Reason for Recall
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Distribution Pattern
Distributed to one U.S. customer in SC.
Code Information
Cat No.: G333 Lot No.: H15055