Dimension Clinical Chemistry System and Xpand System - LIPASE Flex (LIPL) Assay, and Dimension EXL SYSTEM - LIPASE (LIPL) Assay (2017-12-17)
- Starting date:
- December 17, 2017
- Posting date:
- January 9, 2019
- 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-68664
Affected products
- Dimension Clinical Chemistry System - LIPASE Flex (LIPL) Assay
- Dimension Xpand System - LIPASE Flex (LIPL) Assay
- Dimension EXL SYSTEM - LIPASE (LIPL) Assay
Reason
Siemens Healthcare Diagnostics has received customer complaints regarding a positive bias in QC results and patient samples when using Dimension Lipase (LIPL) lot FB8109. Siemens internal investigation has confirmed the positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits. The investigation compared Lot FB8109 with control Lot GB8141 (historical performance representative dimension lipase lot). The lot comparison between dimension LIPL Lot FB8109 and Lot GB8141, when using patient samples, demonstrated an average positive bias of 15%. The range of positive bias of 11% (1028 u/l using Lot GB8141, as reference lot vs 1141 u/l using Lot FB8109) to 22% (94 u/l using Lot GB8141as reference lot vs 114 u/l using Lot FB8109).
Affected products
A. Dimension Clinical Chemistry System - LIPASE Flex (LIPL) Assay
Lot or serial number
FB8109
Model or catalog number
DF56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
B. Dimension Xpand System - LIPASE Flex (LIPL) Assay
Lot or serial number
FB8109
Model or catalog number
DF56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES
C. Dimension EXL SYSTEM - LIPASE (LIPL) Assay
Lot or serial number
FB8109
Model or catalog number
DF56
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101
Newark
19714
Delaware
UNITED STATES