Device product
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.
Z-2192-2015
Product summary
- Event
- Event 71577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,500
- Official record key
device-enforcement:Z-2192-2015
Official wording
Reason: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Code information: Cat No.: G333 Lot No.: H15055
Distribution pattern: Distributed to one U.S. customer in SC.
Derived failure modes
-
Unknown
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.