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Micro SSP Generic HLA DNA Typing Trays (2015-01-06)
- Starting date:
- January 6, 2015
- Posting date:
- February 16, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43707
Recalled Products
A) Micro SSP Generic HLA Class I DNA Typing Trays
B) Micro SSP Generic HLA Class I and II DNA Typing Trays
Reason
Allele information on the specific user documents, SSP-001B-007-WS-00 revision 0, SSP-ABDR-010-WS-00 revision 0, SSP-ABDR-010-WS3-00 revision 0, SSP-ABDX-010-WS-00 revision 0, SSP-ABDX-010-WS3-00 revision 0, SSP-ML02-005-WS-00 revision 0 and SSP-ML02-005-WS3-00 revision 0 (worksheets) is missing and may cause incorrect typing information for analysis completed manually. Typing analysis using HLA fusion software is not impacted by this issue.
Affected products
A) Micro SSP Generic HLA Class I DNA Typing Trays
Lot or serial number
SSP1B: 007, BATCH 1-3
Model or catalog number
SSP1B
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES
B) Micro SSP Generic HLA Class I and II DNA Typing Trays
Lot or serial number
SSPABDR: 010, BATCH 1-5, 7-12
SSPABDRX: 010, BATCH 1
SSPML02: 005, BATCH 1-2
Model or catalog number
SSPABDR
SSPABDRX
SSPML02
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES