| 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 |
|
| 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 |