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ALP LFCC Gen.2 Large and Small Tests (2013-09-16)
- Starting date:
- September 16, 2013
- Posting date:
- October 28, 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-36447
Recalled Products
A. ALP LFCC Gen.2 Large (400 Tests)
B. ALP LFCC Gen.2 Small (200 Tests)
Reason
The manufacturer has identified, during an internal investigation and changed labelling recommendations, that a change was required in the Icteric index (I-index) claim of the alkaline phosphatase (ALP2) assay on the Cobas Integra platform.
Affected products
A. ALP LFCC Gen.2 Large (400 Tests)
Lot or serial number
All lots
Model or catalog number
- 03333701190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
B. ALP LFCC Gen.2 Small (200 Tests)
Lot or serial number
All lots
Model or catalog number
- 03333752190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY