Health product recall

cobas p501 post-analytical units (2019-04-07)

Starting date:
April 7, 2019
Posting date:
April 18, 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-69646



Last updated: 2019-04-18

Affected Products

cobas p501 post-analytical units

Reason

The tray input flap on the cobas p 501 and cobas p 701 post-analytical units has the potential to become unsecured from the instrument. The tray input flap screws can become loose on the cobas p 501 or p 701 post-analytical units resulting in the potential detachment from the instrument.

Affected products

cobas p501 post-analytical units

Lot or serial number

Serial number 1034.

Model or catalog number

5158494001

Companies
Manufacturer

Roche Diagnostics GMBH

Sandhoferstrasse 116

Mannheim

68305

GERMANY