Health product recall

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

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

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

Lot or serial number

All lots.

Model or catalog number

20763454122

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY

B. STFR (Tina-Quant Soluble Transferrin Receptor)

Lot or serial number

All lots.

Model or catalog number

5950821190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY