bacT/ALERT FN Plus (2019-03-25)

Starting date:

March 25, 2019

Posting date:

April 18, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69618

Last updated: 2019-04-18

• 
  Reason
• 
  Affected products

Affected Products

bacT/ALERT FN Plus

Reason

The issue was discovered during a complaint investigation. An error message was generated by the VIRTUO instrument that incorrectly indicated the bottle would be expiring before the end of the culture bottle test cycle. This error message was displayed on the VIRTUO system at the customer's site. The human readable expiration date on the bottle label was correct and the bottle had not expired. The source of the error message was determined to be an incorrect expiration date within the 2D barcode on the bottle label.

Affected products