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Terminated

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***

FDA Recall Z-0480-2011 · Posted 2010-11-26

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeKZJ
Date Initiated2010-08-13
Date Terminated2011-01-05
Product Quantity496 units

Reason for Recall

In vitro diagnostic reagent containers may be defective and could cause incorrect test results in patient samples.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution: USA and the countries of Australila, Belgium, Canada, India, Mexico, New Zealand. Singapore, and South Korea,

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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