BD BBL Gram Stain Kit & Crystal Violet (2020-04-20)

Starting date:

April 20, 2020

Posting date:

May 8, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73025

Last updated: 2020-05-22

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  Reason
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  Affected products

Affected Products

1. BD BBL Gram Stain Kit
2. BD BBL Gram Crystal Violet

Reason

Confirmed customer reports that the products may exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci. Use of products with increased levels of artifacts could result in a false-positive gram stain. Gram stain results must be confirmed with additional procedures, but if these protocols are not followed, a false-positive could lead to administration of unnecessary antibiotics or surgical procedures.

Affected products