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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01054-1
Product Name/Description N Latex ß2–Microglobulin

Catalogue Numbers: OQWU155 and OQWU15

Lot Numbers: 44862, 44902, 44968, 45192, 45229, 45252, 45291, 45329, 45342, 45366, 45470, 45525 and 45543.

ARTG Number: 178153
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 2/11/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue Siemens Healthcare Diagnostics has received complaints from customers not being able to establish a calibration curve or to validate an established calibration curve with the respective controls when using one of the affected lots of N Latex ß2-Microglobulin. The issue might lead to the inability to calibrate the assay or to obtain invalid test runs. However, patient results are not affected.

There is the potential for the user to be exposed to assay components contaminated with Pseudomonas libanensis, Pseudomonas rhodesiae and Pseudomonas extremorientalis. Exposure may lead to an infection and its consequences

A review of previously generated results due to this issue is at the discretion of the laboratory.

Siemens advises that the delay of results for these assays does not represent a hazard, and as a result the severity level is None or Negligible.
Recall Action Recall
Recall Action Instructions Customers are asked to discontinue use of and discard the affected lots listed in the Customer Letter. A replacement or credit will be issued as per the normal procedure. This action has been closed-out on 07/09/2018.
Contact Information 1800 310 300 - Siemens Technical Support Center