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Terminated

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.

FDA Recall Z-2192-2015 · Posted 2015-07-22

Recalling FirmHardy Diagnostics
Recall StatusTerminated
Product CodeJSO
Date Initiated2015-06-24
Date Terminated2015-08-28
Product Quantity1,500

Reason for Recall

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

Firm Action

The firm initially called customers to inform them of the recall. The firm's phone script stated that they were discontinuing the product and as part of the process were recalling anything that still might be within expiration date. The phone script stated that the firm was going to be sending something in writing. On 06/24/15 the firm sent out a notification letters to customers to inform them that they were discontinuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the enclosed form stating their compliance with the above action. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at [email protected].

Root Cause

No Marketing Application

Distribution Pattern

Distributed to one U.S. customer in SC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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