VARIANT NBS Newborn Screening System - Sickle Cell Program (2020-02-27)

Starting date:

February 27, 2020

Posting date:

March 13, 2020

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-72587

Last updated: 2020-03-13

• Reason
• Affected products

Affected Products

VARIANT NBS Newborn Screening System - Sickle Cell Program

Reason

Bio-Rad has found that the printed english VARIANT NBS Sickle Cell Program instructions for use (IFU) included in the lots mentioned above of the VARIANT NBS Sickle Cell Program reorder pack is the incorrect version. It does not match the correct IFU version that is on the included multiple-language CD (MLCD) Kindly note that the differences between the IFU versions do not affect the product performance.

Affected products