Advia Chemistry Systems (2017-02-13)

Starting date:

February 13, 2017

Posting date:

February 28, 2017

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-62416

• Reason
• Affected products

Affected Products

A. Advia Chemistry System - Lactate Dehydrogenase L-P (LDLP) Assay
B. Advia Chemistry System - Lactate Dehydrogenase P-L (LDPL) Assay
C. Advia 1200 Chemistry System - Lactate Dehydrogenase L-P (LDLP) Assay
D. Advia 1200 Chemistry System - Lactate Dehydrogenase P-L (LDPL) Assay

Reason

Siemens Healthcare Diagnostics is providing an update to all Advia Chemistry Systems Lactate Dehydrogenase L-P (LDLP) and Lactate Dehydrogenase P-L (LDPL) assay instructions for use (IFUs). The current Advia Chemistry Systems Lactate Dehydrogenase IFUs intended use section contains the following statements which will be removed:

Advia Chemistry LDLP: They may also be used to monitor cancer therapy.

Advia Chemistry LDPL: They may also be used to monitor extensive cancer and cancer therapy.

The revised IFU intended use for both assays are listed below:

Advia Chemistry LDLP: For in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on Advia Chemistry Systems. Such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.

Advia Chemistry LDPL: For in vitro diagnostic use in the quantitative determination of lactate dehydrogenase activity in human serum and plasma on Advia Chemistry Systems. Such measurements are used mainly in the diagnosis and treatment of myocardial and pulmonary infarction.

Affected products