Health product recall

Liquichek Cardiac Troponins Control (2021-01-08)

Starting date:
January 8, 2021
Posting date:
January 29, 2021
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-74867



Last updated:
2021-01-29

Affected Products 

A. Liquichek Cardiac Troponins Control Level 1

B. Liquichek Cardiac Troponins Control Level 2

C. Liquichek Cardiac Troponins Control Level 2 Minipak

D. Liquichek Cardiac Troponins Control Level 3

E. Liquichek Cardiac Troponins Control Level 3 Minipak

Reason

Bio-Rad has been made aware of a reduced thawed and open vial stability to 8 days instead of 14 days, for the Troponin I Analyte.

Affected products

A. Liquichek Cardiac Troponins Control Level 1

Lot or serial number

56391

Model or catalog number

12001084

12001085

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES


B. Liquichek Cardiac Troponins Control Level 2

Lot or serial number

56392

Model or catalog number

12006239

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES


C. Liquichek Cardiac Troponins Control Level 2 Minipak

Lot or serial number

56392

Model or catalog number

12006370

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES


D. Liquichek Cardiac Troponins Control Level 3

Lot or serial number

56393

Model or catalog number

12006369

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES


E. Liquichek Cardiac Troponins Control Level 3 Minipak

Lot or serial number

56393

Model or catalog number

12006371

Companies
Manufacturer

Bio-Rad Laboratories

9500 Jeronimo Road

Irvine

92618

California

UNITED STATES