Atellica CH 930, IM 1300, and IM 1600 Analyzer (2018-09-30)

Starting date:

September 30, 2018

Posting date:

October 19, 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-67964

• Reason
• Affected products

Affected products

1. Atellica CH 930 Analyzer
2. Atellica IM 1300 Analyzer
3. Atellica IM 1600 Analyzer

Reason

Siemens Healthcare Diagnostics has identified the following issues with the Atellica Solution, which are installed with Atellica Solution software (SW) versions 1.14.2 (SMN 11316393) or lower.

Issue Number 1 - The cover interlocks on the Atellica Magline Transport for the Atellica CH 930 Analyzer, IM 1300 Analyzer, and IM 1600 Analyzer may not work as expected. When an Atellica Magline Transport cover in the front or back of an analyzer is opened, carrier motion may continue and the operator may not be alerted that a cover is open.

Issue Number 2 - The Atellica IM 1300 Analyzer and IM 1600 Analyzer may use the T3/T4/VB12 Ancillary Reagent after expiration. The following scenarios may occur:

• T3 and T4 results generated using expired T3/T4/VB12 Ancillary Reagent are reported with a result flag, "OBS extended".
• VB12 dilution results generated with expired T3/T4/VB12 Ancillary Reagent are not reported with a flag.

Issue Number 3 - The Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer may not calibrate T4. Intermittent failures may occur when calibrating the T4 assay due to observed errors in one or more replicates. The result in the Worklist will be flagged with a "Signal shape error".

Issue Number 4 - The Atellica CH 930 may report incorrect serum indices for Hemolysis, Icterus and Lipemia (H, I, and L) for any test run on the patient sample. The CH analyzer generates H, I, and L serum indices in two ways.

Method 1: If the Setup->Settings->General Setup->Patient->HIL Ordering option is set to "Alwaysorder" or "According to TDef", for samples with one or more of the following tests, ALT, AST, LDLP, and UN_c, the indices are calculated from one of these tests.

Method 2: For samples without one of the tests listed in "Method 1" above, the indices are generated independently and are correct.

The serum indices calculated when 'Method 1' is used may not be consistent with the sample or the independently derived H, I, and L indices using "Method 2".

Affected products