Z-2031-2012 Class II Terminated
FDA device recall Z-2031-2012 was initiated by Becton Dickinson & Co. on Apr 12, 2012 and is designated Class II. Reason for recall: Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. The recall status is terminated (terminated Dec 10, 2012). Affected quantity: 539 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 25, 2012
- Initiation Date
- Apr 12, 2012
- Termination Date
- Dec 10, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 539 kits
Product Description
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Reason for Recall
Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.
Distribution Pattern
Nationwide Distribution.
Code Information
Lot 1348873, Exp April 30, 2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2031-2012
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026