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AllSet Gold SSP (2016-05-06)
- Starting date:
- May 6, 2016
- Posting date:
- July 29, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59590
- AllSet Gold SSP HLA Direct to High Resolution Kit
- AllSet Gold SSP HLA Class I High Resolution Kits
- AllSet Gold HLA Low Resolution Kits
- AllSet + Gold SSP
- AllSet Gold ABDR Low Resolution Kit
- AllSet Gold ABDRQ Low Resolution Kit
Reason
A false negative reaction may be observed in the presence of a*11:01:04, specifically for primers PM118C, PM118F, A11-01 and A11-01A. This could lead to mis-typings during analysis
Affected products
A. AllSet Gold SSP HLA Direct to High Resolution Kit
Lot or serial number
- Lot 12, Batch 1303557
- Lot 12, Batch 1395079
- Lot 12, Batch 1446993
- Lot 12, Batch 1544269
- Lot 12, Batch 1608823
- Lot 12, Batch 1608903
- Lot 12, Batch 1615252
- Lot 12, Batch 1648453
- Lot 12, Batch 68764
Model or catalog number
- 54010D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
B. AllSet Gold SSP HLA Class I High Resolution Kits
Lot or serial number
- Lot 8, Batch 1441210
- Lot 8, Batch 1608856
Model or catalog number
- 541100D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
C. AllSet Gold HLA Low Resolution Kits
Lot or serial number
- Lot 22, Batch 1256853
- Lot 22, Batch 1385981
- Lot 22, Batch 1472871
- Lot 22, Batch 1608858
- Lot 22, Batch 1608939
- Lot 22, Batch 63056
Model or catalog number
- 54310D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
D. AllSet + Gold SSP
Lot or serial number
- Lot 38 Batch 1249868
- Lot 38 Batch 1306788
- Lot 38 Batch 1360419
- Lot 38 Batch 1391657
- Lot 38 Batch 1428080
- Lot 38 Batch 1472869
- Lot 38 Batch 1568517
- Lot 38 Batch 1608870
- Lot 38 Batch 1608950
- Lot 38 Batch 1649364
Model or catalog number
- 54010D
- 541100D
- 54310D
- 54340D
- 54350D
- 54360D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
E. AllSet Gold ABDR Low Resolution Kit
Lot or serial number
- Lot 36, Batch 1255129
- Lot 36, Batch 1304515
- Lot 36, Batch 1357615
- Lot 36, Batch 1399473
- Lot 36, Batch 1441214
- Lot 36, Batch 1472866
- Lot 36, Batch 1544261
- Lot 36, Batch 1608849
- Lot 36, Batch 1608938
- Lot 36, Batch 1615269
- Lot 36, Batch 1624938
- Lot 36, Batch 1649370
- Lot 36, Batch 69962
Model or catalog number
- 54350D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
F. AllSet Gold ABDRQ Low Resolution Kit
Lot or serial number
- Lot 29, Batch 1247232
- Lot 29, Batch 1293558
- Lot 29, Batch 1306794
- Lot 29, Batch 1362561
- Lot 29, Batch 1395129
- Lot 29, Batch 1428078
- Lot 29, Batch 1465433
- Lot 29, Batch 1508463
- Lot 29, Batch 1589667
- Lot 29, Batch 1608890
- Lot 29, Batch 1608960
- Lot 29, Batch 645
- Lot 29, Batch 646
- Lot 29, Batch 647
- Lot 29, Batch 75232
Model or catalog number
- 54360D
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES