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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 Recall
Accuprobe Group B Streptococcus Culture Identification Test,
see related information
Date Posted December 19, 2007
Recall Status1 Terminated on May 03, 2010
Recall Number Z-0145-2008
Recall Event ID 44958
Premarket Notification
510(K) Number
K974572 
Product Classification Dna-Probe, Reagents, Streptococcal - 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, California 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
PRODUCTION CONTROLS: Packaging Process Control
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MDK and Original Applicant = CHUGAI PHARMACEUTICALS CO., LTD.
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