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Roche PCR Instruments (2016-03-17)
- Starting date:
- March 27, 2016
- Posting date:
- April 29, 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-58112
Affected Products
A. COBAS TAQMAN 48 ANALYZER
B. COBAS AMPLIPREP
C. LIGHT CYCLER 2.0 INSTRUMENT V.4.05 IVD
D. COBAS TAQMAN ANALYZER (96)
E. MAGNA PURE LC2.0 INSTRUMENT
F. AMPLILINK SOFTWARE VERSION 3.3.7
G. MAGNA PURE LC INSTRUMENT
Reason
The manufacturer has identified during an internal investigation following a customer complaint, that a poor quality barcode (code 128, grade F) could generate a misidentification using the handheld scanner USB IT3800 (cat # 05401062001 included in the mentioned Roche systems.
Affected products
A. COBAS TAQMAN 48 ANALYZER
Lot or serial number
All lots.
Model or catalog number
3279332001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
B. COBAS AMPLIPREP
Lot or serial number
All lots.
Model or catalog number
3051315001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
C. LIGHT CYCLER 2.0 INSTRUMENT V.4.05 IVD
Lot or serial number
All lots.
Model or catalog number
3531414001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
D. COBAS TAQMAN ANALYZER (96)
Lot or serial number
All lots.
Model or catalog number
3121453001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
E. MAGNA PURE LC2.0 INSTRUMENT
Lot or serial number
All lots.
Model or catalog number
5197686001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
F. AMPLILINK SOFTWARE VERSION 3.3.7
Lot or serial number
All lots.
Model or catalog number
6712673001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY
G. MAGNA PURE LC INSTRUMENT
Lot or serial number
All lots.
Model or catalog number
12236931001
Companies
- Manufacturer
-
Roche Diabetes Care GMBH
SANDHOFER STRASSE 116
MANNHEIM
GERMANY