VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (528 MODEL) (2015-05-26)

Starting date:

May 26, 2015

Posting date:

July 9, 2015

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-54172

• Reason
• Affected products

Recalled Product

A.VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (528 MODEL)

Reason

An internal investigation has shown that the use of the VersaTREK Automated Microbial Detection System might result in false positive reports. To date three (3) customer complaints have been received, all in conjunction with VersaTREK Myco bottle usage. Review of instrument databases suggests that on rare occasions the barometric pressure readings may be inconsistent. This event is caused by a protective sticker covering the sensor. If this sticker forms a complete seal it traps air under the sticker, resulting in incorrect atmospheric pressure readings. This in turn leads to reports of false positives.

Affected products