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Cobas C Pack Large Parts (2013-09-09)
- Starting date:
- September 9, 2013
- Posting date:
- October 16, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-36209
Recalled Products
A. HDLC3 for Cobas C701 Analyser
B. GLUC3 for Cobas C701 Analyser
C. Cobas C 70x Serum Index
D. Ferr4 for Cobas C701 Analyser
E. Alt LFCC
F. Cobas C 70x Ecotergent D
G. Cobas C 70x NAOHD
H. Cobas C 70x SMS
Reason
Issue observed with specific lots of Cobas C pack large where the reagent manager (RM) of the Cobas C702 module may be unable to open the Cobas C pack large. These issues does not affect cobas C701 customers.
Affected products
A. HDLC3 for Cobas C701 Analyser
Lot or serial number
- 68143701
Model or catalog number
- 05168805190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
B. GLUC3 for Cobas C701 Analyser
Lot or serial number
- 68673101
Model or catalog number
- 05168791190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
C. Cobas C 70x Serum Index
Lot or serial number
- 68635701
Model or catalog number
- 05172179190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
D. Ferr4 for Cobas C701 Analyser
Lot or serial number
- 68460401
Model or catalog number
- 05172390190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
E. LFCC
Lot or serial number
- 68760401
Model or catalog number
- 05850797190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
F. Cobas C 70x Ecotergent D
Lot or serial number
- 68627301
Model or catalog number
- 05907543190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
G. Cobas C 70x NAOHD
Lot or serial number
- 68802301
Model or catalog number
- 05172128190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
H. Cobas C 70x SMS
Lot or serial number
- 68802701
Model or catalog number
- 05172136190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY