Dimension Vista Lipase (LIPL), Dimension Clinical Chemistry, EXL and Xpand System - Lipase Flex (LIPL) Assay (2018-09-13)
- Starting date:
- September 13, 2018
- Posting date:
- October 5, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67882
Affected products
A. Dimension Vista Lipase (LIPL)
B. Dimension Clinical Chemistry System -Lipase Flex (LIPL) Assay
C. Dimension Xpand System - Lipase Flex (LIPL) Assay
D. Dimension EXL System - Lipase (LIPL) Assay
Reason
Siemens Healthcare Diagnostics has confirmed lot-to-lot variability for QC and patient results when using the Dimension LIPL lots GD9002, GA9003, GB9032, GA9038 and Dimension Vista LIPL lots 18128BA, 18172BA, 18186BB. Not all laboratories will observe this issue.
The lot-to-lot bias observed for patient samples using the affected Dimension Lots when compared with a control lot could be as high as 29%. The lot-to-lot bias observed for patient samples using the affected Dimension Vista Lots when compared with a control lot ranged from 9% to 34%.
Affected products
A. Dimension Vista Lipase (LIPL)
Lot or serial number
18128BA
18186BB
Model or catalog number
K3056
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension Clinical Chemistry System -Lipase Flex (LIPL) Assay
Lot or serial number
GA9003
GA9038
GB9032
GD9002
Model or catalog number
DC56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
C. Dimension Xpand System - Lipase Flex (LIPL) Assay
Lot or serial number
GA9003
GA9038
GB9032
GD9002
Model or catalog number
DC56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
D. Dimension EXL System - Lipase (LIPL) Assay
Lot or serial number
GA9003
GA9038
GB9032
GD9002
Model or catalog number
DC56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES