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U.S. Department of Health and Human Services

Class 2 Device Recall Accuprobe Group B Streptococcus Culture Identification Test,

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  Class 2 Device Recall Accuprobe Group B Streptococcus Culture Identification Test, see related information
Date Initiated by Firm May 02, 2007
Date Posting Updated December 19, 2007
Recall Status1 Terminated 3 on May 03, 2010
Recall Number Z-0145-2008
Recall Event ID 44958
510(K)Number K974572  
Product Classification Streptococcus Culture Identification Test, - Product Code MDK
Product Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121
Code Information Catalog Number 2820B; Lot Number 531379.
Recalling Firm/
Manufacturer
Gen-Probe Inc
10210 Genetic Center Dr
San Diego CA 92121-4362
For Additional Information Contact Kristin Godfredsen
858-410-8532
Manufacturer Reason
for Recall
Mispackaging: Kits may contain Haemophilus Influenza probe pouches in addition to Group B Streptococcus probe pouches
FDA Determined
Cause 2
Other
Action Gen-Probe notified customers by phone on May 2nd and 3rd, 2007; a recall notice letter was faxed to each customer on May 3rd, 2007 and mailed on May 4th, 2007 via certified mail. The letter describes the packaging error and the remote health hazard risk, and provides instructions for users to return all kits of this lot number.
Quantity in Commerce 106 kits
Distribution Nationwide: including states of AZ, CA, CO, FL, KY, MD, MO, NC, NJ, TX, and UT
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.
510(K) Database 510(K)s with Product Code = MDK and Original Applicant = CHUGAI PHARMACEUTICALS CO., LTD.
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