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Health product recall

P512 PRE-ANALYTICAL SYSTEM (2016-02-22)

Starting date:
February 22, 2016
Posting date:
April 22, 2016
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-57996

Affected products 

A. P512 PRE-ANALYTICAL SYSTEM

Reason

It was observed that sample tubes may be decapped and then not correctly placed back in the rack tube transport. The sample material was spilled and could not be used to carry out the analysis.

Affected products

A. P512 PRE-ANALYTICAL SYSTEM

Lot or serial number

S/N: 4728845

Model or catalog number

5083435001

Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY