Atellica CH Reaction Cuvette Segment (2020-02-17)

Starting date:
February 17, 2020
Posting date:
February 20, 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-72319

Last updated:

Affected Products

Atellica CH Reaction Cuvette Segment

Reason

Siemens Healthcare Diagnostics has determined that a small percentage (<0.5%) of Atellica CH Reaction Cuvette Segment Kit lots ending in "17" or "18" may have cuvette defects allowing water from the water bath to contaminate the interior of the cuvette. Not all cuvette positions within an affected cuvette segment are impacted. There is a potential that sample results obtained at the impacted cuvette positions can be falsely elevated or depressed to varying degrees depending on the assay and the amount of water bath contamination. Quality control samples may or may not detect this issue.

Affected products

Atellica CH Reaction Cuvette Segment

Lot or serial number

More than 10 numbers, please contact the manufacturer. 

Model or catalog number

11099326

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