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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