Instrument Manager (2016-06-28)

Starting date:

June 28, 2016

Posting date:

July 6, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-59210

• Reason
• Affected products

Affected products

A. Instrument Manager

Reason

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.

Affected products