The Recall Desk
HighFDA (Devices)·Z-2048-2020·Announced 2020-05-27

BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive 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, and the hazard involves a risk of diagnostic error (false-positive results) which could lead to inappropriate medical treatment, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Co. is recalling 1,469 units of the BD BBL Gram Stain Kit with Stabilized Iodine, Catalog Number 212539. The recall affects specific lots with expiration dates ranging from March 30, 2021, to July 31, 2021. The product is distributed worldwide, including in the United States, Canada, and various international markets.

The recall was initiated because the kits 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. This issue may impact the accuracy of differential staining of bacteria from cultures or specimens.

Healthcare professionals and laboratories should stop using the affected kits immediately. Users should contact Becton Dickinson for instructions on returning the product or obtaining a replacement. No specific illnesses or injuries have been reported in the source text, but the risk of diagnostic error is the primary concern.

The recalled product

Product
BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - 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.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,469

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)

  • Lot Number/ Exp Date: 0007261 06/30/21
  • 0007255 05/31/21
  • 0028309 03/30/21. Expanded 5/12/20-Lot Numbers/Exp. Date: 0041114 07/31/21
  • 0014322 06/30/21

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.

See all 3 products in this recall →

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