HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10

FDA device recall Z-2192-2015 · posted 2015-07-22 · Terminated

Recall details

Recalling firm

Hardy Diagnostics

Reason for recall

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

Action taken

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 TechService@HardyDiagnostics.com.

Root cause

No Marketing Application

Status

Terminated

Product code

JSO

Quantity affected

1,500

Distribution

Distributed to one U.S. customer in SC.

Date initiated

2015-06-24

Date posted

2015-07-22

Date terminated

2015-08-28

Location

Santa Maria, CA