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