This page has been archived on the Web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.
Cobas 6000 - E601, Modular Analytics E Combinations Analyzer (E170) and Cobas 8000 E602 Immunoassay Analyzer (2014-05-07)
- Starting date:
- May 7, 2014
- Posting date:
- June 5, 2014
- 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-39785
Recalled products
- Cobas 6000 - E601
- Modular Analytics E Combinations Analyzer (E170)
- Cobas 8000 E602 Immunoassay Analyzer
Reason
Loose Procell/Cleancell aspiration tube filter may lead to under or overestimation of parameters on modular analytics E, Cobas E601 and Cobas E602 analyzers.
Affected products
A. Cobas 6000 - E601
Lot or serial number
All serial numbers
Model or catalog number
- 04745922001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
B. Modular Analytics E Combinations Analyzer (E170)
Lot or serial number
All serial numbers
Model or catalog number
- 03023109001
- 03023117001
- 03739040001
- 05023572001
- 05023599001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
C. Cobas 8000 E602 Immunoassay Analyzer
Lot or serial number
All serial numbers
Model or catalog number
- 05990378001
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY