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Roche Diagnostics Assays (2016-10-27)
- Starting date:
- October 27, 2016
- Posting date:
- December 13, 2016
- 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-61374
Affected Products
- C-REACTIVE PROTEIN GEN.3 (CRPL3)
- HITACHI TINA-QUANT C-Reactive Protein (Latex) High Sensitive Assay (CRP)(LA)
- IGM-2 (TINA-QUANT IGM GEN.2) for use on C701 Analyzer
- IMMUNOGLOBULIN M for use on Cobas Integra 400/400 Plus/800 Analyzers
- IGM-2 (TINA-QUANT IGM GEN.2) for use on Cobas C Systems Analyzers
- IGA-2 (TINA-QUANT IGA GEN.2) for use on C701 Analyzer
- IMMUNOGLOBULIN A for use on Cobas Integra 400/400 Plus/800 Analyzers
- IGA-2 (TINA-QUANT IGA GEN.2) for use on Cobas C Systems Analyzers
- IGG-2 (TINA-QUANT IGG GEN.2) for use on C701 Analyzer
- IGG-2 (TINA-QUANT IGG GEN.2) for use on Cobas C Systems Analyzers
Reason
This recall/product correction is related to a possible sample carry-over for some HIA reagent across Roche systems platforms (Cobas C311/501/502/701/702, Modular P and Cobas Integra 800).
Affected products
A. C-REACTIVE PROTEIN GEN.3 (CRPL3)
Lot or serial number
All lots
Model or catalog number
- 04956885190
- 04956923190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. HITACHI TINA-QUANT C-Reactive Protein (Latex) High Sensitive Assay (CRP)(LA)
Lot or serial number
All lots
Model or catalog number
11972855216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. IGM-2 (TINA-QUANT IGM GEN.2) for use on C701 Analyzer
Lot or serial number
All lots
Model or catalog number
05220726190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. IMMUNOGLOBULIN M for use on Cobas Integra 400/400 Plus/800 Analyzers
Lot or serial number
All lots
Model or catalog number
20737771322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
E. IGM-2 (TINA-QUANT IGM GEN.2) for use on Cobas C Systems Analyzers
Lot or serial number
All lots
Model or catalog number
03507190190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
F. IGA-2 (TINA-QUANT IGA GEN.2) for use on C701 Analyzer
Lot or serial number
All lots
Model or catalog number
05219205190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
G. IMMUNOGLOBULIN A for use on Cobas Integra 400/400 Plus/800 Analyzers
Lot or serial number
All lots
Model or catalog number
20737755322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
H. IGA-2 (TINA-QUANT IGA GEN.2) for use on Cobas C Systems Analyzers
Lot or serial number
All lots
Model or catalog number
03507343190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
I. IGG-2 (TINA-QUANT IGG GEN.2) for use on C701 Analyzer
Lot or serial number
All lots
Model or catalog number
05220718190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
J. IGG-2 (TINA-QUANT IGG GEN.2) for use on Cobas C Systems Analyzers
Lot or serial number
All lots
Model or catalog number
03507432190
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY