Database updated: 3 November 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:28526
Brand Name:BioPlex 2200 APLS IgM
Model:
Affected:Catalogue number - 665-2050, 665-2150
Software version:
Recalling Organisation:Bio-Rad New Zealand
Level 30
48 Shortland Street
AUCKLAND 1010
Contact Information:0508 805 500
Manufacturer:Bio-Rad Laboratories Inc
Issue:It has come to the manufacturer attention that there is an error in the IFU in the assay reportable measuring ranges and detection limit tables, and that not all customers may have been updated to the new APF versions.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:29/10/2021
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