CVM Calibration Verification Material (2019-05-16)

Starting date:

May 16, 2019

Posting date:

June 7, 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-70123

Last updated: 2019-06-07

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  Reason
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  Affected products

Affected Products

CVM Calibration Verification Material

Reason

Siemens Healthcare Diagnostics has confirmed an error in the CVM material performance variability range pertaining to the level 1 pCO2 range for the siemens rapidlab 1260/1265 systems, where the correct CVM material performance variability range for pCO2 is 121.3-150.5 mmHg, instead of the published range of 135.1-164.3 mmHg. This is a value assignment issue for performance variability range not a product issue. Only customers with RAPIDLab 1260/1265 systems are affected.

Affected products