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Allset Gold DPB1 High Resolution SSP Kit, DPB1 SSP UniTray 12 Tests and DPB1 SSP UniTray With Taq 12 Tests (2014-08-14)
- Starting date:
- August 14, 2014
- Posting date:
- September 16, 2014
- 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-41365
Recalled products
- Allset Gold DPB1 High Resolution SSP Kit
- DPB1 SSP UniTray 12 Tests and DPB1 SSP UniTray With Taq 12 Tests
Reason
On June 26, 2014, one customer complaint was received for this issue (internal ref. # PR162312): a customer reported that a sample had discrepant results when using SSP UniTray versus two other typing methods. SSP UniTray typed the sample as DPB1*04:01, DPB1*81:01. The correct assignment should be DPB1*04:01, DPB1*33:01. This is considered a mistype result.
Affected products
A. Allset Gold DPB1 High Resolution SSP Kit
Lot or serial number
- 008 1204422
- 008 1256851
- 009 1377591
- 009 1450550
- 009 1544263
Model or catalog number
- 54070D
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES
B. DPB1 SSP UniTray 12 Tests and DPB1 SSP UniTray With Taq 12 Tests
Lot or serial number
- 008 1154360
- 008 1190373
- 008 1220578
- 008 1289713
- 009 1415057
- 009 1464121
- 009 1568516
Model or catalog number
- 451606D
- 451616D
Companies
- Manufacturer
-
Life Technologies Corporation (Invitrogen)
9099 North Deerbrook Trail
Brown Deer
53223
Wisconsin
UNITED STATES