Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage:

FDA device recall Z-2276-2015 · posted 2015-07-29 · Terminated

Recall details

Recalling firm

Hardy Diagnostics

Reason for recall

Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with Ciprofloxacin 1 ug, MDR Acinetobacter, BEA with Azide and Vancomycin, BEA Agar with Vancomycin, Gentamicin, and Amphotericin B, BEA Broth with Vancomycin, and VRE Broth 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 discontinung the product and as part of the process were recalling anything that still might be within expiration date. The instructions provided via phone were to discard any remaining plates that are in stock in order for credit. The phone script stated that the firm was going to be sending something in writing. On 06/25-29/15 the firm sent out notification letters to customers to inform them that they were discontuing the product, and were requested anything remaining within expiration to be discarded. The firm requests that customers complete, sign, and fax back the endlosed form stating their compliance with the above action. The notification states if the laboratory was unable to be reached via telephone and would like a credit to contact the Customer Service Department at 800-266-2222, option 1. For any questions the firm states to contact Technical Services Department at 800-266-222, option 2 or via email at TechService@HardyDiagnostics.com. Follow-up calls will be made to customers who do not respond.

Root cause

No Marketing Application

Status

Terminated

Product code

JSO

Quantity affected

5,940 (5940 pk/10)

Distribution

U.S. Nationwide Distribution and the country of: Canada

Date initiated

2015-06-26

Date posted

2015-07-29

Date terminated

2015-09-11

Location

Santa Maria, CA