Health product recall

Elecsys Anti-CCP (2019-07-05)

Starting date:
July 5, 2019
Posting date:
July 26, 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-70521

Last updated: 2019-07-26

Affected Products

Elecsys Anti-CCP

Reason

Potential false high results may be obtained while using specific lots of Elecsys Anti-CCP on cobas e 411, cobas e 601, cobas e 602 and/or cobas e 801 instruments. This issue may only affect plasma samples and serum samples are not impacted.

Affected products

Elecsys Anti-CCP

Lot or serial number

36802901
36803301
38880001
38915201

Model or catalog number

5031656190
7251670190

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY