Immunoglobulin M, A & G for use on COBAS INTEGRA 400/400 Plus/800 analyzers & Ceru (Ceruloplasmin) (2020-04-03)
- Starting date:
- April 3, 2020
- Posting date:
- May 8, 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-72991
Last updated: 2020-05-08
Affected PRoducts
- Immunoglobulin M for use on COBAS INTEGRA 400/400 Plus/800 analyzers
- Immunoglobulin A for use on COBAS INTEGRA 400/400 Plus/800 analyzers
- Immunoglobulin G for use on COBAS INTEGRA 400/400 Plus/800 analyzers
- Ceru (Ceruloplasmin)
Reason
In order to comply with the prerequisites of IVDR and due to the data basis available for registration, the manufacturer revised the method sheets and application settings for the ceruloplasim, immunoglobulin A, immunoglobulin G and immunoglobulin M assays by removing post-concentration via the rerun function.
The manufacturer advised us of this issue on 21-Mar-2020.
Affected products
A. Immunoglobulin M for use on COBAS INTEGRA 400/400 Plus/800 analyzers
Lot or serial number
- 40673201
- 43205701
Model or catalog number
- 20737771322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
B. Immunoglobulin A for use on COBAS INTEGRA 400/400 Plus/800 analyzers
Lot or serial number
- 37223601
- 42077201
- 43206001
Model or catalog number
- 20737755322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
C. Immunoglobulin G for use on COBAS INTEGRA 400/400 Plus/800 analyzers
Lot or serial number
- 39842701
- 44192701
Model or catalog number
- 20766631322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY
D. Ceru (Ceruloplasmin)
Lot or serial number
- 33547101
- 34001401
- 35404001
- 37706001
- 40763101
- 44494701
Model or catalog number
- 20764663322
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY