| Class 2 Device Recall Accuprobe Group B Streptococcus Culture Identification Test, | |
Date Initiated by Firm | May 02, 2007 |
Date Posted | 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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MDK
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