Elecsys AFP and Elecsys Total PSA (2014-02-17)

Starting date:

February 17, 2014

Posting date:

March 25, 2014

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-38607

• 
  Reason
• 
  Affected products

Recalled Products

A. Elecsys AFP

B. Elecsys Total PSA

Reason

1) An error was detected in the Cobas E602 analyzer application file version 103 for both kits sizes of Elecsys AFP assay. This file version was inadvertently encoded with a 4 points determination for each calibrator level, when the correct determination is 2-fold.

2) There is a reduced onboard stability for the 100 tests kit size with the AFP application file version 104 and the TPSA application file version 103. The onboard stability of the 100 tests kit was harmonized with the 200 tests kit to the stability claim of (28 days) to allow the use of both reagent kit sizes in parallel on the Cobas E602 with the new software version 04-01.

Affected products