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MAS Omni IMMUNE Systems (2014-04-02)
- Starting date:
- April 2, 2014
- Posting date:
- November 25, 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-61218
Affected Products
- A. MAS Omni IMMUNE Level 1
- B. MAS Omni IMMUNE Level 2
- C. MAS Omni IMMUNE Level 3
- D. MAS Omni IMMUNE Pro Level 1
- E. MAS Omni IMMUNE Pro Level 2
- F. MAS Omni IMMUNE Pro Level 3
- G. MAS Omni IMMUNE
- H. MAS Omni IMMUNE Pro
Reason
The constituent, inhibin A, was removed from MAS Omni-IMMUNE and MAS Omni-IMMUNE Pro Controls. However, the package insert was not updated to reflect removal. The affected lots should not be used as control material for monitoring inhibin A assays. No other analytes of the MAS Omni-IMMUNE and MAS Omni-IMMUNE Pro Controls are affected.
Affected products
A. MAS Omni IMMUNE Level 1
Lot or serial number
OIM15091
Model or catalog number
OIM-101
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
B. MAS Omni IMMUNE Level 2
Lot or serial number
OIM15092
Model or catalog number
OIM-202
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
C. MAS Omni IMMUNE Level 3
Lot or serial number
OIM15093
Model or catalog number
OIM-303
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
D. MAS Omni IMMUNE Pro Level 1
Lot or serial number
OPRO15101
Model or catalog number
OPRO-101
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
E. MAS Omni IMMUNE Pro Level 2
Lot or serial number
OPRO15102
Model or catalog number
OPRO-202
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
F. MAS Omni IMMUNE Pro Level 3
Lot or serial number
OPRO15103
Model or catalog number
OPRO-303
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
G. MAS Omni IMMUNE
Lot or serial number
OIM1509S
Model or catalog number
OIM-SP
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES
H. MAS Omni IMMUNE Pro
Lot or serial number
OPR1510S
Model or catalog number
OPRO-SP
Companies
- Manufacturer
-
Microgenics Corporation
46500 KATO ROAD
Fremont
94538
UNITED STATES