Elecsys Anti-TPO (2018-07-11)

Starting date:

July 11, 2018

Posting date:

July 27, 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-67306

• 
  Reason
• 
  Affected products

Affected products

Elecsys Anti-TPO

Reason

An incorrect expiration date (May 2018 instead of Aug 2018) and former Anti-TPO rodbard parameters, including minimum calibration signal limits, are encoded in the e-package of Elecsys Anti-TPO Reagent kit on cobas e 602 module analyzer.

Affected products