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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01292-1
Product Name/Description	HemosIL PT-Fibrinogen HS PLUS, An in-vitro diagnostic medical device (IVD) Part Number: 0008469810 Affected Lot Numbers: N1222324, N0333626, N0735317 and N0148094.
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	12/12/2014
Responsible Entity	Werfen Australia Pty Ltd
Reason/Issue	Vials manufactured prior to June 2014 from the provided batch numbers may exhibit a yellow / brownish colour after reconstitution (yellow colour or darker) instead of the typical white to off-white colour. Vials exhibiting this yellow / brownish colour were observed to cause prolonged clotting times, with several reports of controls being outside of the established ranges. If an affected vial is used with a patient sample, a significant shift in INR greater than 10% could occur with the potential to alter subsequent medical treatment.
Recall Action	Recall
Recall Action Instructions	Werfen is advising their customers not to use any vials identified as part of this recall, discard all boxes of potentially affected lot numbers of product. It is recommended that previously reported test results are reviewed under the supervision of the Medical Director. This acion has been closed-out on 26/08/2016.
Contact Information	1300 369 132 - Werfen