U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.
U.S. Nationwide Distribution and the country of: Canada
제품 설명
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.