Roche Diagnostics Products (HITACHI, COBAS INTEGRA) (2019-01-14)
- Starting date:
- January 14, 2019
- Posting date:
- March 22, 2019
- 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-69374
Affected Products
- HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)
- HITACHI Inorganic Phosphorus (Phos)
- HITACHI Bicarbonate (917,P)
- HITACHI Alpha-Amylase Liquid ACC. to IFCC (Amyl)
- COBAS INTEGRA phosphate (inorganic) ver.2 (Phos2)
- COBAS INTEGRA Bicarbonate Liquid (CO2-L)
- COBAS INTEGRA Uric Acid Ver.2 (UA2)
- COBAS INTEGRA Alpha-Amylase EPS Ver.2 (AMYL2)
- COBAS INTEGRA Creatinine Plus Ver.2 (CREP2)
- COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)
- HITACHI pancreatic-Alpha-Amylase Liquid (P-AMYL)
- HITACHI Total Protein in Urine/Cerebrospinal Fluid (U/CSF Protein)
- HITACHI Gluco-Quant Glucose HK
- HITACHI Uric Acid Plus (UA Plus)
- HITACHI Creatinine Plus (CREA plus)
- HITACHI Bicarbonate Liquid Unisys
- COBAS INTEGRA Glucose HK Gen.3
- COBAS INTEGRA Tina-Quant Albumin Gen.2
- COBAS INTEGRA Creatinine Jaffe Gen.2
- HITACHI Tina-quant Albumin Modular P Antigen Excess Reagent (AlbuXS)
- HITACHI Fructosamine (Fruc)
- COBAS INTEGRA Fructosamine
- COBAS INTEGRA Total Protein Urine/CSF Gen.3 (TPUC3)
- Ethanol Gen.2 (EtOH2) For COBAS INTEGRA And COBAS C Systems
- C-Reactive Protein Gen.3 (CRPL3)
- Albt2 (Tina-quant Albumin Gen. 2) For COBAS C701 Analyzer
- Amy-P (Alpha-Amylase EPS Pancreatic) For COBAS C701 Analyzer
- Amyl2 (Alpha-Amylase EPS Ver.2) For COBAS C701 Analyzer
- Phos2 (Phosphate (Inorganic) Ver.2) For COBAS C701 Analyzer
- CO2-L (Bicarbonate Liquid) For COBAS C701 Analyzer
- Crej2 (Creatinine Jaffe Gen.2) For COBAS C701 Analyzer
- Crep2 (Creatinine Plus Ver.2) For COBAS C701 Analyzer
- Gluc3 (Glucose HK Gen.3) For COBAS C701 Analyzer
- CRPL3 (C-Reactive Protein Gen.3) For COBAS C701 Analyzer
- TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
- TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
- Fra (Fructosamine) For COBAS C701 Analyzer
- EtOH2 (Ethanol Gen. 2) For Roche / HITACHI COBAS C / Cobas C 701
- Mg2
- Mg
- Ca2 (Calcium Gen.2)
Reason
During introduction of a new platform, manufacturer assessed potential risk of endogenous and drug interferences on all Roche tests and corresponding platforms. New endogenous and individual drug interferences were identified for some ClinChem and HIA assays in serum/plasma, urine and CSF used on COBAS c311, c501, c502, c701 and c702 modules.
Affected products
A. HITACHI HICO Creatinine Jaffe Method, Rate-Blanked & Compensated (CREA)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11875418216
- 11875663216
- 11929941216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. HITACHI Inorganic Phosphorus (Phos)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11730347216
- 11875965216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. HITACHI Bicarbonate (917,P)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3289907190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. HITACHI Alpha-Amylase Liquid ACC. to IFCC (Amyl)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11876473316
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. COBAS INTEGRA phosphate (inorganic) ver.2 (Phos2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3183793122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. COBAS INTEGRA Bicarbonate Liquid (CO2-L)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3289923190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
G. COBAS INTEGRA Uric Acid Ver.2 (UA2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3183807190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
H. COBAS INTEGRA Alpha-Amylase EPS Ver.2 (AMYL2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3183742122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
I. COBAS INTEGRA Creatinine Plus Ver.2 (CREP2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3263991190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
J. COBAS INTEGRA Alpha-Amylase EPS Pancreatic (AMY-P)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
20766623322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
K. HITACHI pancreatic-Alpha-Amylase Liquid (P-AMYL)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11876562316
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
L. HITACHI Total Protein in Urine/Cerebrospinal Fluid (U/CSF Protein)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11877801190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
M. HITACHI Gluco-Quant Glucose HK
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11876899216
- 11929534216
- 11929542216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
N. HITACHI Uric Acid Plus (UA Plus)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11929429216
- 11929437216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
O. HITACHI Creatinine Plus (CREA plus)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 11875566216
- 11875582216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
P. HITACHI Bicarbonate Liquid Unisys
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3289885190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
Q. COBAS INTEGRA Glucose HK Gen.3
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4404483190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
R. COBAS INTEGRA Tina-Quant Albumin Gen.2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4469658190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
S. COBAS INTEGRA Creatinine Jaffe Gen.2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4810716190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
T. HITACHI Tina-quant Albumin Modular P Antigen Excess Reagent (AlbuXS)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4999622190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
U. HITACHI Fructosamine (Fruc)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11930010216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
V. COBAS INTEGRA Fructosamine
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
4537939190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
W. COBAS INTEGRA Total Protein Urine/CSF Gen.3 (TPUC3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3333825190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
X. Ethanol Gen.2 (EtOH2) For COBAS INTEGRA And COBAS C Systems
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
3183777190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
Y. C-Reactive Protein Gen.3 (CRPL3)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 4956842190
- 4956885190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
Z. Albt2 (Tina-quant Albumin Gen. 2) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5167043190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AA. Amy-P (Alpha-Amylase EPS Pancreatic) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5167035190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AB. Amyl2 (Alpha-Amylase EPS Ver.2) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5167027190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AC. Phos2 (Phosphate (Inorganic) Ver.2) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5171377190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AD. CO2-L (Bicarbonate Liquid) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5446376191
6407102190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AE. Crej2 (Creatinine Jaffe Gen.2) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6407137190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AF. Crep2 (Creatinine Plus Ver.2) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5168589190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AG. Gluc3 (Glucose HK Gen.3) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5168791190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AH. CRPL3 (C-Reactive Protein Gen.3) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5172373190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AI. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5171954190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AJ. TPUC3 (Total Protein Urine/CSF Gen.3) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5171857190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AK. Fra (Fructosamine) For COBAS C701 Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5171962190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AL. EtOH2 (Ethanol Gen. 2) For Roche / HITACHI COBAS C / Cobas C 701
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5967104190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AM. Mg2
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6407358190
6481647190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AN. Mg
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
11551353216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
AO. Ca2 (Calcium Gen.2)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
5061431190
5061458190
5061482190
5168449190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY