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.
Reported: July 29, 2015 Initiated: June 24, 2015 #Z-2192-2015
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.
Details
- Recalling Firm
- Hardy Diagnostics
- Units Affected
- 1,500
- Distribution
- Distributed to one U.S. customer in SC.
- Location
- Santa Maria, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hardy Diagnostics. Units affected: 1,500.
Why was this product recalled? ▼
Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 29, 2015. Severity: Moderate. Recall number: Z-2192-2015.
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