Dimension Ammonia Assays (2016-12-23)

Starting date:

December 23, 2016

Posting date:

January 18, 2017

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-61832

• Reason
• Affected products

Affected Products

1. Dimension Vista System - Ammonia Assay
2. Dimension EXL System - Ammonia Assay
3. Dimension Xpand System - Ammonia Assay
4. Dimension Clinical Chemistry - AMM Assay

Reason

Siemens has determined that five (5) lots of Dimension Ammonia Assay (DF119) and three (3) lots of Dimension Vista Ammonia Assay (K3119) Flex Reagent Cartridges do not meet the 60-day calibration interval claim due to reagent instability and may show an abnormal assay message. These lots may exhibit accuracy shifts for patient and/or quality control results. This may cause laboratories to recalibrate more frequently than the 60-day claim in the IFU.

Affected products