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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01101-1
Product Name/Description Liquid Assayed Multiqual Premium (multi analyte control material). An in vitro diagnostic medical device (IVD)

Master lot number 15900

Level 1 lot number: 15901; Catalogue number: 284

Level 2 lot number: 15902; Catalogue number: 285

Level 3 lot number: 15903; Catalogue number: 286

Trilevel MiniPak lot number: 15900; Catalogue number: 285X
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 30/10/2012
Responsible Entity Bio-Rad Laboratories Pty Ltd
Reason/Issue Bio-Rad has observed that Fructosamine does not meet the stability and performance claims stated in the package insert.
Recall Action Recall for Product Correction
Recall Action Instructions Bio-Rad is providing updated package insert for the affected lots which now indicates that there are no stability or performance claims for Fructosamine.
Contact Information 1800 224 354 - Bio-Rad Laboratories