BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
FDA Recall Z-1423-2013 · Posted 2013-05-29
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Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodeJTO
Date Initiated0013-04-12
Date Terminated2013-09-28
Product Quantity610 total test kits (PYR and Oxidase)
Reason for Recall
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Firm Action
BD Diagnostic Systems sent an Urgent Product Recall" letter dated April 2013 to all affected consignees and end users. The letter identified the affected product, problem and actions to be taken. The notice instructed consignees and end users to discontinue use of the products, discard remaining products, and return a completed response form. Consignees were requested to provide contact information for end users who received recalled product in distribution, to allow for recall notice. The letter included instructions to report injuries and/or illnesses to Medwatch, and address recall inquiries to BD Technical Services at 1-800-638-8663.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
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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