Health product recall

Atellica CH A-LYTE Integrator Multisensor (2020-03-27)

Starting date:
March 27, 2020
Posting date:
April 24, 2020
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-72853

Last updated: 2020-04-24

Affected Products

Atellica CH A-LYTE Integrator Multisensor

Reason

Siemens Healthcare Diagnostics has confirmed that the A-LYTE integrated multisensor (imt NA, K, CL), lot number 190006, may not routinely meet the instructions for use (IFU) onboard stability claim of 14 days or 5000 samples.

Affected products

Atellica CH A-LYTE Integrator Multisensor

Lot or serial number

190006

Model or catalog number

11099315

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

New York

UNITED STATES