SYNCHRON Systems Lipase (LIP) Reagent (2018-09-11)

Starting date:

September 11, 2018

Posting date:

October 5, 2018

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-67886

• 
  Reason
• 
  Affected products

Affected products

SYNCHRON Systems Lipase  (LIP) Reagent

Reason

Control and patient samples tested with lip reagent lot M712448 may recover lower than those tested with other lots. Samples below 100 U/L may recover up to 10.7 U/L lower. Samples above 100 U/L may recover up to 8.9% lower. Lower recovery of lip in control samples may exceed the lower limits of a laboratory's established QC range or published insert range.

Affected products