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U.S. Department of Health and Human Services

Class 2 Device Recall GBS Detect

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  Class 2 Device Recall GBS Detect see related information
Date Initiated by Firm March 21, 2016
Create Date April 26, 2016
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-1571-2016
Recall Event ID 73688
Product Classification Culture media, selective and non-differential - Product Code JSJ
Product Hardy Diagnostics GBS Detect
Cat no. A300.

Used for the isolation and detection by enhanced hemolysis of gamma-hemolytic (non-hemolytic) Group B Streptococcus.
Code Information Lot H16054 and H15056.
Recalling Firm/
Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information Contact Technical Services Department
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 3,530 (353 pk/10)
Distribution U.S. Distribution to the following states: AL, SC, FL, CT, VA, WI, MA, MI, WV, OH, IN, IL, NC, and TX.
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.