ARCHITECT System - Creatine Kinase Assay (2018-07-20)

Starting date:

July 20, 2018

Posting date:

August 2, 2018

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-67350

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  Reason
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  Affected products

Affected products

ARCHITECT System - Creatine Kinase Assay

Reason

The purpose of this is to inform customers of a product recall for the ARCHITECT Creatine Kinase (CK) reagent and to provide instructions on what actions must be taken. Abbott has identified a stability issue that may lead to the following issues.

• Error Code 1054 ""Unable to calculate results, Reaction Check Failure.
• Quality control (QC) results out of range low.

A potential delay may exist in the reporting of patient results due to quality control values falling outside of expected ranges and the generation of error code 1054. Internal testing on patient samples showed no atypical bias for the impacted reagent lots, therefore if quality controls are in range, patient results are not impacted.

Affected products