ATELLICA CH 930 ANALYZER (2019-08-01)

Starting date:

August 1, 2019

Posting date:

August 9, 2019

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-70679

Last updated: 2019-08-09

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  Reason
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  Affected products

Affected Products

ATELLICA CH 930 ANALYZER

 

Reason

Siemens Healthcare Diagnostics, Inc. is informing customers that the Atellica CH 930 Analyzer may report incorrect serum indices for Hemolysis (H) and Lipemia (L) when using the UN_c test as a donor method, and the Hemolysis Icterus Lipemia (HIL) function is enabled. Due to bubbles in the reaction cuvette, there is a potential for falsely depressed H results (e.g. H index of 3 or higher, reported as ¿1 ) at a rate of 0.3-1% and falsely elevated L results (e.g. L index of 0 reported as ¿ 1) at a rate of 2.9%. In all cases of falsely depressed H results, the L results will be elevated ¿1. For samples not using UN_c as the donor method the indices are not affected. THE DONOR METHOD THE INDICES ARE NOT AFFECTED.

Affected products