ABL800 Flex Analyzer (2018-06-25)

Starting date:

June 25, 2018

Posting date:

July 5, 2018

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-67174

• 
  Reason
• 
  Affected products

Affected products

ABL800 Flex Analyzer

Reason

Creatinine measurements, as determined on abl8x7 analyzers, could be underestimated with up to 28%. This may lead to erroneous measurement values for CREA and may lead to no detection of renal insufficiency or underestimation of moderate to severe renal failure.

Affected products