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.
FDA Recall Z-2174-2010 · Posted 2010-08-05
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLLH
Date Initiated2010-03-05
Date Terminated2010-10-15
Product Quantity31 kits
Reason for Recall
In vitro diagnostic test kits do not perform to specifications.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.