Recall Z-2192-2015— Hardy Diagnostics
Class II · Terminated
Class II FDA medical device recall by Hardy Diagnostics, initiated 2015-06-24, terminated 2015-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance..
- Recalling firm
- Hardy Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-24
- Terminated
- 2015-08-28
- Firm location
- Santa Maria, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.