| Class 2 Device Recall VRE Broth | |
Date Initiated by Firm | June 26, 2015 |
Date Posted | July 29, 2015 |
Recall Status1 |
Terminated 3 on September 11, 2015 |
Recall Number | Z-2279-2015 |
Recall Event ID |
71602 |
Product Classification |
Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
|
Product | Hardy Diagnostics
VRE Broth, 5ml
container type: 16x100mm tube
packaged: 20 tubes/box
fill: 5ml
Product Usage:
BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting. |
Code Information |
Lot number: 15021, 15043, 15072, 15126, 15152 Cat no. K103 |
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 | 900 each (90 pk/10) |
Distribution | U.S. Nationwide Distribution and the country of: Canada |
Total Product Life Cycle | TPLC Device Report |
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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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