Health product recall

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

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

A. Atellica IM 1300 Analyzer

Lot or serial number

IM00882
IM00952
IM00987
IRM008822003
IRM008852003
IRM009022004
IRM08782003
Im00425

Model or catalog number

11066001

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES

B. ATELLICA IM 1600 ANALYZER

Lot or serial number

IH00244
IH00255
IH00259
IH01519
IH01520
IRH008672002

Model or catalog number

11066000

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES