Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21002
Brand Name: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA)
Model:
Affected: 161028142817JH
Software version:
Recalling Organisation:Abacus ALS Limited
55b Richard Pearse Drive
Airport Oaks
Auckland 2022
Contact Information:0800 222 170
Manufacturer:IMMY
Issue:As part of post-market surveillance activities, the Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) were found to have reduced specificity (90% now versus 99% before).
Recall action type:Recall
Recall action:Product to be destroyed
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:12/1/2017
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