Drug recall
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as…
FDA recall event 66933 · Class II · Becton Dickinson & Co.
Key facts
| Event ID | 66933 |
|---|---|
| Recall numbers | Z-0790-2014 |
| Recalling firm | Becton Dickinson & Co. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 11, 2013 |
| Report date | Jan 29, 2014 |
| Termination date | Feb 19, 2014 |
| City | Sparks |
| State | MD |
| Country | United States |
| FEI number | 1119779 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: