Becton Dickinson Recalls Gram Crystal Violet Stain Reagents
Becton Dickinson is recalling Gram Crystal Violet 250 mL reagents due to potential artifacts that may interfere with the identification of microorganisms.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential artifacts that may interfere with diagnostic accuracy, but no specific injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Becton Dickinson & Co. is recalling 878 cartons (3,512 bottles) of Gram Crystal Violet 250 mL, catalog #212525. The affected lots are 1325324 (Exp May 31, 2013) and 2011746 (Exp July 31, 2013). These products were distributed nationwide.
The recall was initiated because the reagents have the potential to produce an increased level of artifacts. These artifacts may appear as large, spherical, and easy to distinguish, or as small and more difficult to distinguish from Gram-positive cocci. This issue may affect the accuracy of the differential Gram method used to stain microorganisms from cultures or specimens.
Healthcare facilities and laboratories should stop using the affected lots and contact Becton Dickinson for instructions on return or replacement. Consumers are not directly affected as this is a professional laboratory reagent.
The recalled product
- Product
- 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.
- Manufacturer
- Becton Dickinson & Co.
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 (4)
- Lots 1325324 Exp May 31
- 2013 and 2011746
- Exp July 31
- 2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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