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Health product recall

Immunoassay Quality Control Material (2015-­10-­07)

Starting date:
October 7, 2015
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-55852

Affected Products

  1. Immunoassay Quality Control Material
  2. Immunoassay Quality Control Material
  3. Immunoassay Quality Control Material
  4. Immunoassay Quality Control Material
  5. Immunoassay Quality Control Material

Reason

Parathyroid hormone (PTH) is present in the control material but no claim is now made for the expected value or stability of this analyte.

Affected products

A. Immunoassay Quality Control Material

Lot or serial number

All lots

Model or catalog number

IA3112

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM

B. Immunoassay Quality Control Material

Lot or serial number

All lots

Model or catalog number

IA3109

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM

C. Immunoassay Quality Control Material

Lot or serial number

All lots

Model or catalog number

IA2638

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM

D. Immunoassay Quality Control Material

Lot or serial number

All lots

Model or catalog number

IA2639

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM

E. Immunoassay Quality Control Material

Lot or serial number

All lots

Model or catalog number

IA2640

Companies
Manufacturer
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM