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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00416-1
Product Name/Description Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagnostic medical device)
(reagent used for the isolation of HLA Class II+ cells from human peripheral blood)

Catalogue Number: 21004D

Lot Numbers:
135384110 (Expiry Date: 09/2014)
142281200 (Expiry Date: 02/2015)

ARTG Number: 212748
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 8/04/2014
Responsible Entity Life Technologies Australia Pty Ltd
Reason/Issue The manufacturer of Dynabeads HLA Class II, Life Technologies AS, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of HLA Class II cells required for further testing. Lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
Recall Action Recall
Recall Action Instructions Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.
Contact Information 1800 636 327 - Life Technologies Australia Pty Ltd