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

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  Reason
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  Affected products

Affected products

1. Dimension Clinical Chemistry System - LIPASE Flex (LIPL) Assay
2. Dimension Xpand System - LIPASE Flex (LIPL) Assay
3. 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