BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
This recall has been terminated (originally issued May 29, 2013).
- Recall Initiated
- April 12, 0013
- Posted
- May 29, 2013
- Terminated
- September 28, 2013
- Recall Number
- Z-1422-2013
- Quantity
- 610 total test kits (PYR and Oxidase)
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Distribution
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Lot / Code Info
PYR kit - lot 2276481 with expiration date 09/30/13
Root Cause
Mixed-up of materials/components
Action Taken
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.