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Allset Gold and SSP Unitray low resolution kits (2013-10-22)
- Starting date:
- October 22, 2013
- Posting date:
- March 20, 2014
- 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-38461
Recalled Products
A. Allset Gold ABDR low resolution kit
B. Allset Gold ABDRQ low resolution kit
C. Allset Gold DR low resolution kit
D. Allset Gold DRDQ low resolution kit
E. SSP Unitray - low resolution class II
F. SSP Unitray - low resolution combination (Class I and Class II)
Reason
It has been identified that SSP primer mix, PMR 014G, incorrectly identifies the following alleles as having an expected positive reactivity: DRB1*11:09/83/87/113, DRB1*13:05:01-05:02/06/26:02/42/56/136. Therefore, the customer would see a false negative according to their documentation in the presence of any of the above listed alleles.
Affected products
A. Allset Gold ABDR low resolution kit
Lot or serial number
54350D
Model or catalog number
036 1255129
036 1304515
036 1357615
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
B. Allset Gold ABDRQ low resolution kit
Lot or serial number
54360D
Model or catalog number
029 1247232
029 1293558
029 1306794
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
C. Allset Gold DR low resolution kit
Lot or serial number
54370D
Model or catalog number
020 1205205
020 1303555
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
D. Allset Gold DRDQ low resolution kit
Lot or serial number
54380D
Model or catalog number
030 1216651
030 1272183
031 1312025
031 1377599
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
E. SSP Unitray - low resolution class II
Lot or serial number
78400-10
78401-10
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
F. SSP Unitray - low resolution combination (Class I and Class II)
Lot or serial number
78100-10
78101-10
78200-10
78500-10
78501-10
Model or catalog number
More than 10 numbers, contact manufacturer
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES