Home / Recalls / Hardy Diagnostics / Z-2192-2015

Z-2192-2015 Class II Terminated

Recalled by Hardy Diagnostics — Santa Maria, CA

Recall Details

Product Type
Devices
Report Date
July 29, 2015
Initiation Date
June 24, 2015
Termination Date
August 28, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,500

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.

Distribution Pattern

Distributed to one U.S. customer in SC.

Code Information

Cat No.: G333 Lot No.: H15055

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