Z-2319-2012Class II

BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc...

Name: Z-2319-2012 BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc...
Creator: Becton Dickinson & Co.
Published: 2012-05-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-05-22 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC... on 2012-05-22. FDA classified it as Class II and gives the reason as "Leakage in Cepheid SmartCycler reaction tubes". 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-2319-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-09-06
Terminated: 2012-11-02
Recalling firm: Becton Dickinson & Co
Product: BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 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 from 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.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: Leakage in Cepheid SmartCycler reaction tubes.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostic Systems issued an Urgent Product Recall letter via UPS overnight delivery on May 22, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue use and discard any affected product. BD would send replacement tubes for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance FAX: 410-316-4258 Email: [email protected] If further assistance is needed, customers should contact BD Technical Services Department at 1-800-838-8663. For questions regarding this recall call 410-316-4054.
Quantity in commerce: 32 kits
Distribution: Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
Product codes and lots: Lot/ Exp. 08T11250 2012-07-06

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2319-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2316-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06
Z-2317-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06
Z-2318-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06
Z-2319-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06
Z-2320-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code LLH

K081920Class IBd Geneohm Cdiff AssayBd Diagnostics (Geneohm Sciences, Inc.) / cleared 2008-12-19

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)