Health product recall

Ceruloplasmln assay, Alinity c Ceruloplasmin Reagent Kit (2019-06-28)

Starting date:
June 28, 2019
Posting date:
July 15, 2019
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-70423

Last updated: 2019-07-15

Affected Products

A. Ceruloplasmln assay
B. Alinity c Ceruloplasmin Reagent Kit

Reason

Package insert of the ceruloplasmin assay lists the EDTA as suitable anticoagulant for sampling collection tube. However, the EDTA sample tube storage claims are not met with the new studies performed. In particular, the stability claims of 2 weeks at 2-8 degrees celsius and 8 days at room temperature are not confirmed, both for dipotassium and for tripotassium EDTA.

Affected products

A. Ceruloplasmln assay
 

Lot or serial number

All serial numbers.

Model or catalog number

6K91-30

Companies
Manufacturer

Sentinel Ch Spa

Via Robert Koch, 2

Milan

20152

ITALY

B. Alinity c Ceruloplasmin Reagent Kit

Lot or serial number

All lots.

Model or catalog number

09P9320

Companies
Manufacturer

Sentinel Ch Spa

Via Robert Koch, 2

Milan

20152

ITALY