Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1422-2013Class II

BBL DrySlide PYR Kit, catalog number 231747

Becton Dickinson & Co / Terminated / root cause: packaging

Becton Dickinson & Co. began a recall of BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria. FDA classified it as Class II and gives the reason as "In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1422-2013
Classification
Class II
Status
Terminated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Product code
JTO Discs, Strips And Reagents, Microorganism Differentiation
Reason for recall
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Root cause tag
packaging
FDA root cause
Mixed-up of materials/components
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.
Quantity in commerce
610 total test kits (PYR and Oxidase)
Distribution
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Product codes and lots
PYR kit - lot 2276481 with expiration date 09/30/13

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1422-2013
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1422-2013Class IITerminatedVoluntary: Firm initiated
Z-1423-2013Class IITerminatedVoluntary: Firm initiated