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.
데이터 추가 비고
Culture media, selective and non-differential - Product Code JSJ
원인
Performance failure; poor hemolytic reaction of non or weakly hemolytic group b streptococcus (gbs) with the target qc organism, streptococcus agalactiae (atcc 13813) due to product deterioration.
조치
On 03/21/2016 customers were notified by phone, and were sent a notification letter.
Customers were instructed via phone call to discard remaining plates of the implicated lot, and to notify the firm of how many plates are left. The firm stated that they will be issuing replacements. The firm stated that they will be sending written notification as well. The firm requested full name and e-mail or fax number in order to follow-up with the written notification.
The customer notification letter instructs customers to complete, sign, scan/e-mail or fax back enclosed form stating compliance with the action regarding the specific lot. The firm requests the form be returned to the attention of the Quality Assurance Department at techservice@hardydiagnostics.com, fax number 805-614-9274. If the lab is unable to be reached via telephone and would like replacements or credit contact Customer Service Department at 800-266-2222, option 1. Replacements will be sent out at no charge.
Any questions contact Technical Services Department at 800-266-2222, option 2 or via e-mail at techservice@hardydiagnostics.com.
U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
제품 설명
Hardy Diagnostics GBS Detect || Cat no. A300. || Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.