Rapid QC Complete Solution Level 2 (2019-01-02)

Starting date:

January 2, 2019

Posting date:

January 23, 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-68894

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  Reason
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  Affected products

Affected products

Rapid QC Complete Solution Level 2

Reason

Siemens healthcare diagnostics has confirmed that RapidQC complete solution, level 2, lot numbers 362801 and 362802, contain incorrect value assignments for the reported targets and ranges for both glucose and lactate. This incorrect value assignment is present for RAPIDPoint 405/500 Blood Gas Systems and RAPIDLab 1260/1265 Systems.

Affected products