FDA-Device2015-07-29Class II

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.

Hardy Diagnostics
Hazard

Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance.

Sold states
Distributed to one U.S. customer in SC.
Affected count
1,500
Manufactured in
1430 W Mccoy Ln, N/A, Santa Maria, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2192-2015

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