FDAFDA · Food and drugs·Recall number Z-2046-2020
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.
Published May 27, 2020 · Recall initiated: April 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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