Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21000
Brand Name:Pak Lx Assay
Model:
Affected:Lot # 3003658 and 3004022
Software version:
Recalling Organisation:Diagnostic Solutions Pty Ltd
170 Fulham Road
Fairfield
VIC 3078
Australia
Contact Information:0800 448 018
Manufacturer:Immucor Gamma
Issue:The manufacturer has identified, that the Conjugate Diluent included in Lot # 3003658 and 3004022 has an expiration date specified on its labeling which is outside that supported by the stability data. The expiration date for the Conjugate Diluent should be one year shorter than that provided on the labels.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:10/1/2017
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