BD Phoenix" ID/AST Panels, Item # PMIC/ID-107, Catalog number 448607, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA (800) 638-8663***
FDA Recall Z-0366-2011 · Posted 2010-11-15
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeLON
Date Initiated2010-05-14
Date Terminated2010-11-29
Product Quantity1675 units
Reason for Recall
The diagnostic reagent packaging may not be completely sealed, which may cause substrate degradation, and produce incorrect test results, including false positive and false negative results.
Firm Action
BD Diagnostic Systems issued an "Urgent Product Recall" letter dated May 2010 to direct accounts, identifying the affected product, potential impact, and actions to be taken by the customer. Accounts were requested to respond by returning the enclosed reply form indicating the number of replacements needed for the affected product to be discarded.
For assistance iwth replacements, contact BD Customer Service at 800 675-0908. For other inquiries, contact BD Technical Services at 1 800-638-8663.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution: To direct accounts in CA, MD, NJ, PA. and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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