Recall Z-1352-2008 ยท MCB Antigen, C. Difficile
Biosite Inc
Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121
| Date | Mar 27, 2008 (initiated Dec 4, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974881 | TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN A Biosite Incorporated, Mar 20, 1998 |