Z-2046-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 14, 2020
- Termination Date
- February 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,568 bottles
Product Description
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Reason for Recall
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
Code Information
Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21