Hardy Diagnostics recalls HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 1…

Recall date

June 24, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2192-2015

FDA classification

Class II

Brand / firm

Hardy Diagnostics

Sold / distributed

Distributed to one U.S. customer in SC.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.