Recall Z-2318-2012— Becton Dickinson & Co.

Name: FDA recall Z-2318-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-22

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-05-22, terminated 2012-11-02. It names one FDA 510(k) clearance: K081920. Product: BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.. Reason: Leakage in Cepheid SmartCycler reaction tubes..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Terminated: 2012-11-02
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K081920 — BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, Inc.)·cleared 2008-12-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens fr.om patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.

Reason for recall

Leakage in Cepheid SmartCycler reaction tubes.

Data sourced from openFDA. This site is unofficial and independent of the FDA.