Hardy Diagnostics: Medical Device Recall in 2015 - (Recall #: Z-2192-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 24, 2015

Date Posted: July 29, 2015

Recall Number: Z-2192-2015

Event ID: 71577

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,500

Code Information:

Cat No.: G333 Lot No.: H15055

Distribution Pattern:

Distributed to one U.S. customer in SC.

Voluntary or Mandated:

Voluntary: Firm initiated