GasPak EZ Large Incubation Container, a component of the GasPak EZ Gas Generating Container System, catalog # 260672, la
FDA device recall Z-0480-2011 · posted 2010-11-26 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KZJ
- Quantity affected
- 496 units
- Distribution
- Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,
- Date initiated
- 2010-08-13
- Date posted
- 2010-11-26
- Date terminated
- 2011-01-05
- Location
- Sparks, MD
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