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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00507-1
Product Name/Description MIA FORA NGS FLEX 11 HLA Typing Kit. An in vitro diagnostic medical device (IVD).

Product Number: TL-SR-800-10433-24

Lot Number: 18-299-11-C

ARTG Number: 288368
(Abacus dx - Multiple human leukocyte antigens (HLA) typing IVDs)
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 14/05/2018
Responsible Entity Abacus dx Pty Ltd
Reason/Issue Abacus have been notified by the manufacturer, BioArray Solutions, that Lot # 18-299-11-C contains a subassembly kit (MIA FORA NGS FLEX HLA PCR Kit 2 (Lot 18-299)) with an incorrect expiration date of 2109-04-30 instead of 2019-04-30.

No other subassemblies within Lot 18-299-11-C are impacted and no other MIA FORA NGS FLEX 11 HLA Typing Kit lot numbers are affected.
Recall Action Product Defect Correction
Recall Action Instructions Abacus is requesting users to identify impacted product and correct the PCR kit 2 expiry date to 2019.

This action has been closed out on the 26/11/2018.
Contact Information 1800 222 287 - Abacus