Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent
Becton Dickinson & Co. is recalling BD BBL Gram Crystal Violet stain because increased artifacts may cause false-positive Gram stain results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (false-positive diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Becton Dickinson & Co. is recalling 236 bottles of BD BBL Gram Crystal Violet 3.8L, an in vitro diagnostic (IVD) primary stain used for staining microorganisms. The product is identified by Catalog Number 212526. The recall covers specific lot numbers with expiration dates ranging from May 31, 2021, to August 31, 2021.
The recall was initiated because the product may exhibit increased levels of artifacts. These artifacts could be difficult to distinguish from gram-positive cocci, potentially resulting in a false-positive Gram stain. The affected products were distributed worldwide, including in the United States, Canada, and various countries in Asia, Europe, and the Americas.
Healthcare facilities and laboratories should stop using the affected lots and contact Becton Dickinson & Co. for instructions on returning the product. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 236
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Number/ Exp Date: 317740 06/30/21
- 9296637 05/31/21. Expanded 5/12/20 Lot numbers:: 9296631 05/31/21
- 0027824 08/31/21.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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