Cobas Integra Tina-Quant Soluble Transferrin Receptor (STFR) and STFR (Tina-Quant Soluble Transferrin Receptor) (2019-09-05)

Starting date:

September 5, 2019

Posting date:

September 20, 2019

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-71019

Last updated: 2019-09-20

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  Reason
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  Affected products

Affected Products

1. Cobas Integra Tina-Quant Soluble Transferrin Receptor (STFR)
2. STFR (Tina-Quant Soluble Transferrin Receptor)

Reason

During feasibility study for the new STFR assay generation, the manufacturer observed that the rheumatoid factors interference cannot be confirmed for the current STFR assay. Therefore, the claim will be updated to no significant interfereence of rheumatoid factors up to a concentration of 150iu/ml for cobas c system and 120 iu/ml for cobas integra 400 plus analyzer.

Affected products