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