Z-1352-2008

Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego...

Name: Z-1352-2008 Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego...
Creator: Biosite Inc
Published: 2007-12-04
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2007-12-04 / Terminated / root cause: manufacturing process

FDA source

Biosite Inc began a recall of Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121 on 2007-12-04. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1352-2008
Status: Terminated
Initiated: 2007-12-04
Posted: 2008-03-27
Terminated: 2012-03-20
Recalling firm: Alere San Diego, Inc.
Product: Triage Micro ClostrIdium difficile (C.difficile) Panel, Catalog No: 96000, BIOSITE INCORPORATED, San Diego, CA 92121
Product code: MCB Antigen, C. Difficile
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.
Root cause tag: manufacturing process
FDA 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 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
Product codes and lots: Lot Numbers: 180263, 187303, 181472, 183607, 181471, 188135, 185593, 186624, 187398, 190790, and 189158

Product code MCB

K974881Class ITriage C. Difficile, Triage C. Difficile Panel, Triage C. Difficile Toxin aBiosite Incorporated / cleared 1998-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)