Product Wiki · Recalls · Health Canada — Medical Devices

Dimension Clinical Chemistry System and Xpand System — recall 58757

Health Canada — Medical Devices · Canada · 2019-01-09 · Type III

As described by Health Canada — Medical Devices: Dimension Clinical Chemistry System and Xpand System - LIPASE Flex (LIPL) Assay, and Dimension EXL SYSTEM - LIPASE (LIPL) Assay (2017-12-17)

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Agency
Health Canada — Medical Devices
Recall identifier
58757
Date of alert
2019-01-09
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/dimension-clinical-chemistry-s

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