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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1422-2013 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1423-2013 | Class II | Terminated | Voluntary: Firm initiated |
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