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U.S. Department of Health and Human Services

Class 2 Device Recall Triage Micro ClostrIdium difficile (C.difficile) Panel

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  Class 2 Device Recall Triage Micro ClostrIdium difficile (C.difficile) Panel see related information
Date Initiated by Firm December 04, 2007
Date Posted March 27, 2008
Recall Status1 Terminated 3 on March 20, 2012
Recall Number Z-1352-2008
Recall Event ID 46307
510(K)Number K974881  
Product Classification Micro ClostrIdium difficile (C.difficile) Panel, - Product Code MCB
Product Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121
Code Information Lot Numbers: 180263, 187303, 181472, 183607, 181471, 188135, 185593, 186624, 187398, 190790, and 189158
Recalling Firm/
Manufacturer		 Biosite Inc
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact Carmen Bergelin
858-805-2256
Manufacturer Reason
for Recall		 False Lower Results: Toxin A results in the Triage Micro C. difficile Panel have shown falsely lower visual signals (color strength) in certain lots compared to results observed with previous lots.
FDA Determined
Cause 2		 Process design
Action Consignees located in the United States received an Urgent Medical Device Recall Letter notification by United Parcel Service on 12/4/2007 and 12/14/2007. Consignees outside of the United States were notified by Federal Express on 12/4/2007 and 12/14/2007. The Customer Recall Letter with attached fax-back Verification form informed customers of the recall and instructed customers to dicontinue use, discard appropriately all affected kits and complete and FAX the enclosed Verification form. Contact information was also provided form the recalling firm. (USA-(800) 640-0640 )
Quantity in Commerce 4,549 kits
Distribution Worldwide- USA, Argentina, Australia, Belgium, Canada, Switzerland, Colombia, The Czech Republic, Germany, France, Greece, Guatemala, Hong Kong, Croatia, India, Italy, Mexico, Portugal, Sweden, Turkey & The United Kingdom
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 = MCB and Original Applicant = BIOSITE INCORPORATED
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