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Cobas Integra - ALTL, ALTLP, ALTPM and ALT (2014-08-01)
- Starting date:
- August 1, 2014
- Posting date:
- August 15, 2014
- 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-41033
Recalled products
- Cobas Integra Alanine Aminotransferase (ALTL)
- Cobas Integra ALTLP
- ALTPM (Alanine Aminotranferase with Pyroxidal Phosphate Activation)
- ALT (Alanine Aminotransferase) IFCC
Reason
The reason for the recall is related to revised hemolysis claims for the alanine aminotransferase both with and without pyrodoxal activation.
Affected products
A. Cobas Integra Alanine Aminotransferase (ALTL)
Lot or serial number
All lots
Model or catalog number
- 20764957322
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
B. Cobas Integra ALTLP
Lot or serial number
All lots
Model or catalog number
- 04467388190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
C. ALTPM (Alanine Aminotranferase with Pyroxidal Phosphate Activation)
Lot or serial number
All lots
Model or catalog number
- 05531462190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
D. ALT (Alanine Aminotransferase) IFCC
Lot or serial number
All lots
Model or catalog number
- 05850797190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY