Hardy Diagnostics recalls HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packag

Recalled July 29, 2015 · FDA recall Z-2192-2015 · Hardy Diagnostics

Hazard

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

Units

1,500

Sold at

Distributed to one U.S. customer in SC.

Description

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

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.

Manufacturer(s)

Hardy Diagnostics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →