VANC2 and Vancomycin (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO (2016-05-26)

Starting date:

May 26, 2016

Posting date:

June 13, 2016

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-58842

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  Reason
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  Affected products

Affected products

1. VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO
2. VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITAC

Reason

A reference standardization of the Roche vancomycin assays was done by the manufacturer against the reference method. It was decided to correct both methods against the reference method. The COBAS INTEGRA assay was corrected by a reagent modification. The instruction for use of the vancomycin assays already show a method comparison against COBAS INTEGRA with the changed formulation which is not yet available on the market. This may lead to the assumption that both methods are comparable and may affect the interpretation of results. Since the COBAS INTEGRA reagent is not yet adapted, results generated with COBAS INTEGRA are still up to 20% higher than with cobas c or modular p systems.

Affected products