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