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Products Recalled by Roche Diagnostics GMBH (2015-01-19)
- Starting date:
- January 19, 2015
- Posting date:
- February 16, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43705
Recalled Products
A) Hitachi Alpha-Amylase Liquid ACC. to IFCC (Amyl)
B) COBAS INTEGRA System - Lactate Dehydrogenase IFCC
C) COBAS INTEGRA Alpha-Amylase EPS Ver.2 (Amyl2)
D) COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)
E) COBAS INTEGRA Creatine Kinase-MB (CKMBL)
F) Hitachi Pancreatic-Alpha-Amylase Liquid (P-Amyl)
G) Roche Hitachi - LDH (IFCC Liquid) Assay
Reason
Potential to obtain falsely low results without a flag in samples with high turbidity and high kinetic activity. This issue affects only CKMBL, LDH and amylase (pancreatic and total) assays.
Affected products
A) Hitachi Alpha-Amylase Liquid ACC. to IFCC (Amyl)
Lot or serial number
All lots.
Model or catalog number
11876473316
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
B) COBAS INTEGRA System - Lactate Dehydrogenase IFCC
Lot or serial number
All lots.
Model or catalog number
03004732122
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
C) COBAS INTEGRA Alpha-Amylase EPS Ver.2 (Amyl2)
Lot or serial number
All lots.
Model or catalog number
03183742122
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
D) COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)
Lot or serial number
All lots.
Model or catalog number
20766623322
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
E) COBAS INTEGRA Creatine Kinase-MB (CKMBL)
Lot or serial number
All lots.
Model or catalog number
04525299190
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
F) Hitachi Pancreatic-Alpha-Amylase Liquid (P-Amyl)
Lot or serial number
All lots.
Model or catalog number
11876562316
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY
G) Roche Hitachi - LDH (IFCC Liquid) Assay
Lot or serial number
All lots.
Model or catalog number
03002209122
Companies
- Manufacturer
-
Roche Diagnostics GmbH
Sandhofer Strasse 116
Mannheim
68305
GERMANY