This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Instrument Manager Software (Using Roche Cobas E411 Driver)
- Starting date:
- December 3, 2012
- Posting date:
- February 4, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-20221
Recalled Products
A. Instrument Manager Software (Using Roche Cobas E411 Driver)
Reason
When using the Roche Cobas E411 (RCHCE41I) driver version 8.00.0001 or 8.00.0002, if there is a barcode read error, the current sample may be identified as the last sample ID that was in that rack or disk position potentially causing sample mismatch. If the last sample had any pending tests in the orders database, test selection would be downloaded to the instrument with the incorrect sample ID, and results would be reported on the wrong sample.
Affected products
A. Instrument Manager Software (Using Roche Cobas E411 Driver)
Lot or serial number
- Version 8.00.0001
- Version 8.00.0002
Model or catalog number
- 8.00.0001
- 8.00.0002
Companies
- Manufacturer
- Data Innovations LLC