Atellica IM 1300 & 1600 Analyzer (2020-10-29)

Starting date:

October 29, 2020

Posting date:

November 13, 2020

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-74299

Last updated:
2020-11-13

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  Reason
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  Affected products

Affected Products

A. Atellica IM 1300 Analyzer

B. ATELLICA IM 1600 ANALYZER

Reason

Siemens Healthcare Diagnostics has identified an issue with the Atellica Solution products (Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer) through investigation of customer complaints for software (SW) versions V1.23.1 (SMN 11485021) or lower.

When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values.

Affected products