Z-2174-2010

BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du...

Name: Z-2174-2010 BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du...
Creator: Becton Dickinson & Co.
Published: 2010-03-05
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2010-03-05 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended... on 2010-03-05. The reason FDA records is "In vitro diagnostic test kits do not perform to specifications". 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-2174-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-08-05
Terminated: 2010-10-15
Recalling firm: Becton Dickinson & Co
Product: BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** Intended for use as an aid in diagnosis of CDAD.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: In vitro diagnostic test kits do not perform to specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm notified accounts by an Urgent Product Recall letter on 03/05/2020. The letter identified the affected product and explained the reason for recall. It also advised customers to discontinue use of the affected product and discard any remaining inventory and fax back an acknowledgement form. The letter stated that BD will provide replacements for any discarded product. Further assistance can be obtained by contacting BD Technical Service at 1-888-436-3646.
Quantity in commerce: 31 kits
Distribution: Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
Product codes and lots: Lot/Exp date: 08T09101 2010-06-30 08T09101A 2010-06-30 08T09103 2010-07-02

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)