Dimension Systems-Ammonia Assays (2017-03-07)

Starting date:

March 7, 2017

Posting date:

March 24, 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-62788

• Reason
• Affected products

Affected Products

A. Dimension Exl System-Ammonia (Amm) Assay
B. Dimension Xpand System-Ammonia (Amm) Assay
C. Dimension Exl System-Ammonia (Amm) Assay

Reason

In September 2014, Siemens Healthcare Diagnostics issued customer notification 14-62 that addressed a high rate of "abnormal assay" test report messages for its Dimension Ammonia (AMM) Assay. With this letter, Siemens is reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM instructions for use (IFU) revision E will reflect this change.
The new version of dimension software, 10.2, will do the following: 

• automatically move to a new well every day. This decrease in the open well maximum duration reduces the amount of time the AMM reagent is exposed to any potential contaminates, reduces the need for customers to manually move to a new reagent well, and aids in the prevention of erroneous flagging.
• contain the below mean factor limit of 0.90.

Siemens is working to make Dimension Software10.2 available to all customers as quickly as possible.

Affected products