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U.S. Department of Health and Human Services

Class 2 Device Recall MDR Acinetobacter

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  Class 2 Device Recall MDR Acinetobacter see related information
Date Initiated by Firm June 26, 2015
Date Posted July 29, 2015
Recall Status1 Terminated 3 on September 11, 2015
Recall Number Z-2275-2015
Recall Event ID 71602
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
Product Hardy Diagnostics
MDR Acinetobacter

container type: 15x100mm monoplate
packaged: 10 plates/sleeve

Product Usage:
MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.
Code Information Lot number: 15092, 15101, 15113 Cat no. G259
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W Mccoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact
800-266-2222 Ext. 5674
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
Action 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.
Quantity in Commerce 650 (65 pk/10)
Distribution U.S. Nationwide Distribution and the country of: Canada
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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