Product Wiki · Recalls · Health Canada — Medical Devices

VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (528 MODEL)… — recall 54045

Health Canada — Medical Devices · Canada · 2015-07-09 · Type III

As described by Health Canada — Medical Devices: VERSATREK AUTOMATED MICROBIAL DETECTION SYSTEM (528 MODEL) (2015-05-26)

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Agency
Health Canada — Medical Devices
Recall identifier
54045
Date of alert
2015-07-09
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/versatrek-automated-microbial-

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