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COBAS 6500 (2015-12-29)
- Starting date:
- December 29, 2015
- Posting date:
- January 22, 2016
- 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-56762
Affected Products
A. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
B. COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
Reason
It was found that a sample mismatch may occur while using a cobas microscopy analyzer. The tubes are not pipetted according to tube detection, but starting from position one and continuing according to the amount of read barcode labels.
Affected products
A. COBAS 6500 U601 URINALYSIS SYSTEM - URINE ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
06390498001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. COBAS 6500 - COBAS U701 MICROSCOPY ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
06390501001
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY