Z-0790-2014Class II

BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as...

Name: Z-0790-2014 BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as...
Creator: Becton Dickinson & Co.
Published: 2013-10-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-10-11 / Terminated / root cause: labeling and UDI

FDA source

Becton Dickinson & Co. began a recall of BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du... on 2013-10-11. FDA classified it as Class II and gives the reason as "An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0790-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-11
Posted: 2014-01-17
Terminated: 2014-02-19
Recalling firm: Becton Dickinson & Co
Product: BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B 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.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Becton Dickinson sent an Urgent Product Recall Letter dated October 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. They were advised that a portion of the BD GeneOhm Cdiff assay test kits from one lot, 08T13108, may contain incorrect bags of sample buffer tube. Customers were requested to return response forms indicating acknowledgement of the recall and quantity of remaining product that was discarded. Please fax to 410-316-4258.
Quantity in commerce: 33 kits
Distribution: US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
Product codes and lots: Lot 08T13108 Exp Dec 24 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0790-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0790-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-17

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)