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SSP Unitray High/Low Resolution Class I and Low Resolution Combination (Class I) (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-59608
Affected products
- SSP Unitray - High Resolution Class I
- SSP Unitray - Low Resolution Class I
- SSP Unitray - Low Resolution Combination (Class I)
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. SSP Unitray - High Resolution Class I
Lot or serial number
- Lot 12, Batch 1306793
- Lot 12, Batch 1467113
- Lot 12, Batch 1580702
- Lot 12, Batch 1608873
- Lot 8, Batch 1221254
- Lot 8, Batch 1491675
- Lot 8, Batch 1608863
- Lot 8, Batch 1649580
Model or catalog number
- 47080-2
- 47081-2
- 47290-10
- 47291-10
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
B. SSP Unitray - Low Resolution Class I
Lot or serial number
- Lot 22, Batch 1256848
- Lot 22, Batch 1465419
- Lot 22, Batch 1608916
- Lot 22, Batch 1649631
- Lot 38, Batch 1221266
- Lot 38, Batch 1322136
- Lot 38, Batch 1409795
- Lot 38, Batch 1472876
- Lot 38, Batch 1608825
- Lot 38, Batch 1608926
Model or catalog number
- 78000-10
- 78001-10
- 78600-10
- 78601-10
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES
C. SSP Unitray - Low Resolution Combination (Class I)
Lot or serial number
- Lot 29, Batch 1255127
- Lot 29, Batch 1414737
- Lot 29, Batch 1472861
- Lot 29, Batch 1544273
- Lot 29, Batch 1608868
- Lot 36, Batch 1316325
- Lot 36, Batch 1409794
- Lot 36, Batch 1544275
- Lot 36, Batch 1608914
Model or catalog number
- 78100-10
- 78101-10
- 78500-10
- 78501-10
Companies
- Manufacturer
-
One Lambda Inc
21001 Kittridge Street
Canoga Park
California
UNITED STATES