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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01072-1
Product Name/Description Bio-Rad Multispot HIV-1 / HIV-2 Rapid Test. An in vitro diagnostic medical device (IVD)

Catalogue Number: 25228

Reagent Kit Lot Number: 114284

Conjugate Lot number: 114280

ARTG Number: 53509
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 23/10/2012
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad Laboratories has received reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membranes when using some vials of Conjugate in the Multispot HIV-1 / HIV-2 Rapid Test.
Recall Action Recall
Recall Action Instructions Bio-Rad are recalling all affected lots and recommending the retesting of patient samples reported as negative under certain circumstances and at the discretion of the Laboratory Director.
Contact Information 1800 224 354 - Bio-Rad Laboratories