Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent
Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test 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 is classified as FDA Class II. The hazard involves a risk of false-positive diagnostic results due to artifacts, which is a significant risk-of-harm scenario where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Becton Dickinson & Co. is recalling 10,568 bottles of BD BBLTM Gram Crystal Violet 250mL, an in vitro diagnostic (IVD) primary stain used for staining microorganisms. The product is used in Gram Stain Kits and Reagents to stain microorganisms from cultures or specimens using the differential Gram method. The affected product has the catalog number 212525.
The recall is being conducted because the product may exhibit increased levels of artifacts that could be difficult to distinguish from gram-positive cocci. These artifacts could result in a false-positive Gram stain. The recall covers specific lot numbers with expiration dates ranging from April 30, 2021, to July 31, 2021, including lots 9269800, 9296589, 9317733, 9352487, 9352484, and 9352492.
The affected product was distributed worldwide, including in the United States, Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, and Singapore. Users of this product should stop using the affected lots and contact Becton Dickinson for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 10,568
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 (5)
- 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
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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