Events

Recall of Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Thyroid Stimulating Hormone (TSHL) LOCI Free Thyroxine (FT4L) Thyroid Stimulating Hormone (TSH) Cardiac Troponin I (CTNI) Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here

Type of Event
Recall
Event ID
RC-2017-RN-01350-1
Event Risk Class
Class II
Event Initiated Date
2017-10-24
Event Country
Australia
Event Source
DHTGA
Event Source URL
https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01350-1
Notes / Alerts

Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
In march 2017, siemens healthcare issued an urgent recall for product correction vc 17-04 (tga ref: rc-2017-rn-01350-1) regarding incorrect units for biotin listed in the non-interfering substances section of select instructions for use in dimension and dimension vista assays. the ongoing investigation by siemens has identified the following new information regarding biotin interference:1. biotin interference limits are incorrectly listed in the instructions for use (ifu) for the affected assays. these concentrations of biotin can potentially result in interference >10%; and2. the dimension vista ctni, mmb, and dimension siro method ifus do not contain biotin interference information. concentrations of biotin can potentially result in interference >10%.Siemens is continuing to investigate biotin interference with our assays and more information will be forthcoming. the probability of misinterpretation of results due to this issue is unlikely.
Action
Siemens is advising users of the correct biotin interference levels for the affected assays. A lookback of previously generated results is not recommended.

Device

Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD) Th...

Model / Serial
Various Dimension and Dimension Vista LOCI Assays. An in vitro diagnostic medical device (IVD)Thyroid Stimulating Hormone (TSHL)LOCI Free Thyroxine (FT4L)Thyroid Stimulating Hormone (TSH)Cardiac Troponin I (CTNI)Mass creatine kinase MB isoenzyme (MMB)Sirolimus (SIRO)Multiple Catalogue Numbers and SMNs (see attached)All Lots (including all future lots until the IFU is updated)ARTG Numbers: 182774, 182220, 180109 & 181687
Manufacturer
Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd

Manufacturer Parent Company (2017)
Siemens AG
Source
DHTGA

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