System Control N+P, STA - Coag Control N+P & Unicalibrator - STA (2019-11-19)

Starting date:

November 19, 2019

Posting date:

December 13, 2019

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-71861

Last updated: 2019-12-13

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  Reason
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  Affected products

Affected Products

1. System Control N+P, STA - Coag Control N+P
2. Unicalibrator, STA

Reason

Following a customer complaint, Stago has investigated and confirmed that a positive bias exists on the STA - Unicalibrator levels with STA - deficient IX and STA - deficient VIII when compared to the international Standard (IS) for factor VIII or IX. This bias is also observed on several external quality assessment results.

Affected products