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Allset+ Gold Locus High Resolution Kits (2017-06-27)
- Starting date:
- June 27, 2017
- Posting date:
- July 17, 2017
- 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-63998
Affected Products
A. Allset+ Gold Ssp C Locus High Resolution Kit
B. Allset+ Gold Ssp C Low Resolution Kit
C. Allset+ Gold Abc Low Resolution Kit
Reason
Lot specific user documents and software UCH files for primer mixes PM074D and C15-02A contain the incorrect allele specificity.
Affected products
A. Allset+ Gold Ssp C Locus High Resolution Kit
Lot or serial number
005-0000090149
005-0000100555
005-0000115881
005-0000129631
005-0000171299
Model or catalog number
54030D
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES
B. Allset+ Gold Ssp C Low Resolution Kit
Lot or serial number
021-0000090150
021-0000101444
021-0000123224
Model or catalog number
54330D
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES
C. Allset+ Gold Abc Low Resolution Kit
Lot or serial number
038-0000090151
038-0000101440
038-0000117687
038-0381649364
Model or catalog number
54340D
Companies
- Manufacturer
-
One Lambda Inc.
21001 Kittridge Street
Canoga Park
91303-2801
California
UNITED STATES