Health product recall

Atellica CH 930 Analyzer (2019-03-24)

Starting date:
March 24, 2019
Posting date:
April 29, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69782

Last updated: 2019-04-30

Affected Products

Atellica CH 930 Analyzer

Reason

Siemens healthcare diagnostics is informing customers regarding an issue on the Atellica CH 930 analyzers, which are installed with Atellica Solution Software (SW) versions v1.17 SP2 (SMN 11469659) and lower where a difference in results of greater than 10% has been observed between auto-diluted and manually diluted patient samples for results above the assay measuring interval on the Atellica CH 930 Analyzer. Samples within the measuring interval do not require dilution and are not impacted.

Affected products

Atellica CH 930 Analyzer

Lot or serial number

CM00237
CM00238
CM00239
CM00416

Model or catalog number

11067000

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES