Recall Z-0480-2011 ยท KZJ Device, Gas Generating
Becton Dickinson & Co.
GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, labeled in part ***Becton Dickinson and Company Loveton Circle Sparks, MD 21152 USA***
| Date | Nov 26, 2010 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples. |
| Root cause | Nonconforming Material/Component |
| Action | BD Diagnostic Systems issued an Urgent Product Recall letter dated August 2010 to consignees. Consignees were advised of the defect and were requested to discard product for replacement. Distributors were additionally requested to provide distribution lists of end users for direct BD notification. Accounts were requested to return a response form. BD Customer Service can be contacted at 800 675-0908, and BD Technical Services can be contacted at 800-638-8663. |
| Quantity | 496 units |
| Distribution | Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.