Z-1422-2013 Class II Terminated
FDA device recall Z-1422-2013 was initiated by Becton Dickinson & Co. on Apr 12, 2013 and is designated Class II. Reason for recall: In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories. The recall status is terminated (terminated Sep 28, 2013). Affected quantity: 610 total test kits (PYR and Oxidase).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 5, 2013
- Initiation Date
- Apr 12, 2013
- Termination Date
- Sep 28, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 610 total test kits (PYR and Oxidase)
Product Description
BBL DrySlide PYR Kit, catalog number 231747 Product Usage: Presumptive diagnostic aid for group A streptococci and group D enterococci bacteria.
Reason for Recall
In-vitro diagnostic agents were placed into incorrect packaging for distribution to microbiological laboratories.
Distribution Pattern
Worldwide Distribution - USA Nationwide and tthe countries of Australia, Canada, Europe, Hong Kong, Mexico, New Zealand, Singapore, and Taiwan.
Code Information
PYR kit - lot 2276481 with expiration date 09/30/13
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1422-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026