Z-2032-2012 Class II Terminated
FDA device recall Z-2032-2012 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: 878 cartons/ 3512 bottles.
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
- 878 cartons/ 3512 bottles
Product Description
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. 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
Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2032-2012
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026