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