The Recall Desk
ModerateFDA (Devices)·Z-2031-2012·Announced 2012-07-25

Becton Dickinson Recalls BD Gram Stain Kits Due to Staining Artifacts

Becton Dickinson is recalling 539 BD Gram Stain Kits because increased artifacts may interfere with the distinction between microorganisms.

What this means for you

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, but the hazard is a technical staining artifact rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Becton Dickinson & Co. is recalling 539 units of the BD Gram Stain Kit. The product consists of a 250 mL bottle of Gram Crystal Violet and additional reagents, including Gram Iodine (Stabilized), Gram Decolorizer, and Gram Safranin. These kits are used to stain microorganisms from cultures or specimens using the differential Gram method.

The recall was initiated due to a potential for an increased level of artifacts to appear. These artifacts may present as large, spherical, and easy to distinguish, or as small and more difficult to distinguish from Gram-positive cocci. This issue could affect the accuracy of the staining process.

The affected product is identified as Lot 1348873, with an expiration date of April 30, 2013. The recall covers nationwide distribution. Users of the product should stop using the affected kits and contact Becton Dickinson & Co. for further instructions.

The recalled product

Product
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Laboratory Reagents
Hazard
Affected units
539

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 1348873
  • Exp April 30
  • 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.

See all 2 products in this recall →

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