Recall Z-2174-2010 ยท LLH Reagents, Clostridium Difficile Toxin
Becton Dickinson & Co.
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.
| Date | Aug 5, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | In vitro diagnostic test kits do not perform to specifications. |
| 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 | 31 kits |
| Distribution | Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081920 | BD GENEOHM CDIFF ASSAY Bd Diagnostics (Geneohm Sciences, Inc.), Dec 19, 2008 |