Health product recall

Elecsys Anti-TPO (2018-07-11)

Starting date:
July 11, 2018
Posting date:
July 27, 2018
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-67306

Affected products

Elecsys Anti-TPO

Reason

An incorrect expiration date (May 2018 instead of Aug 2018) and former Anti-TPO rodbard parameters, including minimum calibration signal limits, are encoded in the e-package of Elecsys Anti-TPO Reagent kit on cobas e 602 module analyzer.

Affected products

Elecsys Anti-TPO

Lot or serial number

22084503
22084504

Model or catalog number

06368590190

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY