Product Wiki · Recalls · Health Canada — Medical Devices

Instrument Manager (2016-06-28) — recall 55153

Health Canada — Medical Devices · Canada · 2016-07-06 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
55153
Date of alert
2016-07-06
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Quality control (QC) results without a QC Specimen ID (SID) are being filed with patient results that follow it in the same message on Instrument Manager Siemens DPC Cirrus lMMULITE/ lMMULITE/VersacCell (DPCImmui) driver. If the Cirrus lMMULITE, lMMULITE one, lMMULITE 1000, lMMULITE 2000, lMMULITE 2500, or lMMULITE XPI instrument is running in uni-directional mode and is configured to automatically send QC results to the laboratory information system (LIS) and Specimen IDs are not added to QC samples, then QC results received by IM without a Specimen ID will be added to the first specimen received after these QC results in the same ASTM message.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/instrument-manager-2016-06-28

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