Roche Hitachi System 704/717/747 Analyzers (2019-12-05)
- Starting date:
- December 5, 2019
- Posting date:
- January 20, 2020
- 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-72113
Last updated: 2020-01-21
Affected Products
- Roche Hitachi System 704/717/747 Analyzers - Class 2
- Cobas Integra Glucose HK Gen.3
- Cobas Integra Tina-Quant Albumin Gen.2
- Cobas C 111 Phosphorus (PHOS2)
- Cobas C 111 Uric Acid (UA2)
- Cobas C 111 A-Amylase (AMYL2)
- Cobas C 111 CREJ2 - Creatinine Jaffe
- Cobas C 111 CREP2 - Creatinine Plus
- CO2-L (Bicarbonate Liquid) for Cobas C111 Analyzer
- CA2 (Calcium Gen.2)
- PHOS2 (Phosphate (Inorganic) VER.2)
- TPUC3 (Total Protein Urine /CSF Gen.3)
- TPUC3 (Total Protein Urine /CSF Gen.3)
- CO2-L (Bicarbonate Liquid)
- AMY-P (Alpha-Amylase EPS Pancreatic)
- ETOH2 (Ethanol Gen.2)
- CREP2 (Creatinine Plus Ver. 2)
- CREJ2 (Creatinine Jaffe Gen. 2)
- UA2 (Uric Acid VER.2)
Reason
Following the internal study (conducted by the manufacturer) on endogenous and drug interference which identified new endogenous interferences claims (RR201836), additional endogenous and individual drug interferences were identified, but were evaluated not likely to cause a relevant medical risk to patients and users. Therefore, method sheets for the cobas c 111, cobas c 311/501/502, cobas c 701/702 and cobas Integra 400 Plus platforms will be updated with new interference claim. In addition, the reduced concentration of the urea interference claim for all cobas c analyzers for amyl2/amy-p is stated.
Affected products
A. Roche Hitachi System 704/717/747 Analyzers - Class 2
Lot or serial number
29695701
30558501
30558801
32402901
32403201
39993801
Model or catalog number
10759350190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Cobas Integra Glucose HK Gen.3
Lot or serial number
37118201
38172101
39105101
39929101
40879901
42138401
43230301
44444401
Model or catalog number
4404483190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Cobas Integra Tina-Quant Albumin Gen.2
Lot or serial number
32279101
34022301
34852501
36281701
37742301
39087401
40384301
41549301
42591701
44042501
Model or catalog number
4469658190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. Cobas C 111 Phosphorus (PHOS2)
Lot or serial number
37138201
39515401
42227901
44681301
Model or catalog number
05401780190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. Cobas C 111 Uric Acid (UA2)
Lot or serial number
38914401
41582001
43133201
Model or catalog number
4657608190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. Cobas C 111 A-Amylase (AMYL2)
Lot or serial number
38408201
40169901
42941601
44053901
Model or catalog number
05401496190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
G. Cobas C 111 CREJ2 - Creatinine Jaffe
Lot or serial number
31788801
35247501
38184001
41615101
Model or catalog number
05401755190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
H. Cobas C 111 CREP2 - Creatinine Plus
Lot or serial number
39514801
40633501
41561401
42448801
Model or catalog number
05401470190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
I. CO2-L (Bicarbonate Liquid) for Cobas C111 Analyzer
Lot or serial number
35776601
36579401
36759901
39391901
Model or catalog number
5061482190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
J. CA2 (Calcium Gen.2)
Lot or serial number
36293901
37154501
40148501
40821801
42933501
Model or catalog number
5061504190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
K. PHOS2 (Phosphate (Inorganic) VER.2)
Lot or serial number
36040901
38580801
40875201
40881101
41738501
42820301
42857401
44076201
Model or catalog number
3183793122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
L. TPUC3 (Total Protein Urine /CSF Gen.3)
Lot or serial number
36286301
38650201
40738901
43134901
Model or catalog number
3333825190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
M. TPUC3 (Total Protein Urine /CSF Gen.3)
Lot or serial number
38412101
39928101
41581501
43654501
Model or catalog number
3183742122
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
N. CO2-L (Bicarbonate Liquid)
Lot or serial number
32903701
33635801
36578401
36756301
36759201
38892301
39390701
39391601
40218901
Model or catalog number
3289923190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
O. AMY-P (Alpha-Amylase EPS Pancreatic)
Lot or serial number
38412701
40445201
41777001
43655201
Model or catalog number
20766623322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
P. ETOH2 (Ethanol Gen.2)
Lot or serial number
42820301
Model or catalog number
3183777190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
Q. CREP2 (Creatinine Plus Ver. 2)
Lot or serial number
38876501
38981202
40558001
41817801
42052701
42284101
43470801
Model or catalog number
3263991190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
R. CREJ2 (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
S. UA2 (Uric Acid VER.2)
Lot or serial number
38427601
41580001
43180101
Model or catalog number
3183807190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY