VANC3 ONLINE TDM Vancomycin Gen.3 (2019-08-12)

Starting date:

August 12, 2019

Posting date:

August 30, 2019

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-70835

Last updated: 2019-09-05

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  Reason
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  Affected products

Affected Products

VANC3 ONLINE TDM Vancomycin Gen.3

Reason

Potential of inaccurately low results for vancomycin in individual patient samples measured with online TDM Vancomycin Gen.3 (VANC3) assay on cobas c systems. The frequency of occurrence of this situation is considered remote.

Affected products