Health product recall

Iron Gen.2 (2021-05-10)

Starting date:
May 10, 2021
Posting date:
May 26, 2021
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-75663

Last updated: 2021-05-26

Affected Products

Iron Gen.2

Reason

The manufacturer informed us, following customer complaints regarding the increased recovery of controls and discrepant elevated results for the IRON2 on cobas c 311/501/502 and on COBAS INTEGRA 400 plus, of throughput dependent signal drifts with our assay IRON 2 (cat# 03183696122) on cobas c311, cobas c 501/502 and COBAS INTEGRA®400 plus analyzers.

Affected products

Iron Gen.2

Lot or serial number
  • All lots. 
Model or catalog number
  • 03183696122
Companies
Manufacturer
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY