Lithium Assay System (2019-07-16)

Starting date:

July 16, 2019

Posting date:

July 26, 2019

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-70531

Last updated: 2019-07-26

• 
  Reason
• 
  Affected products

Affected Products

1. Lithium Assay
2. Alinity c Lithium Reagent Kit

Reason

An incident occurred on architect instrument for intermittent false high Lithium results, the cause has been identified in the carryover of LDH reagent 1 which contains Lithium when the test is performed on a sub-optimal performing instrument. To prevent occurrence of such an event, and as a preventive protection of patient health, an additional smartwash step is recommended for the Lithium assay. A field action is required in order to advise end users to add this additional step.

Affected products