| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01532-1 |
| Product Name/Description |
Ready-Prep %CDT by HPLC using the CDM software version MVC133091. An in vitro diagnostic medical device (IVD)
Catalogue Number: 1956670, 1956671
Serial numbers: 64121977, 64139856, 64139684, 64142119, 64121979
Expiry Date: 15-03-2018
ARTG Number: 194835 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Bio-Rad have observed that the lot numbers for Mobile Phase 2 [MP][2] and Mobile Phase 3 [MP][3] on the CD-ROM cover print and within the method for the CDM software are not correct for the affected CD-ROM, due to a defect in the manufacturing process of the CD-ROM.
Thus, the printed numbers on the CD-ROM do not correspond to the correct lot numbers of Mobile Phase 2 and Mobile Phase 3 which were delivered with the associated kits.
The wrong lot numbers within the CDM method will affect only customers using the CDM software:
The wrong lot numbers within the method of the CDM software will result in transfer of the wrong lot numbers into the users CDM software, and false lot numbers printed in the summary reports of the analytical runs. This may result in difficulties of the traceability of used mobile phases. Due to the fact that the wrong lot numbers are not used for any other reagents or components of any %CDT by HPLC test there is no risk of false traceability. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Bio-Rad is advising users to immediately check the documentation obtained by using the CD-ROM of the affected lots. If users have used the CD-ROM to read in the lot numbers into the CDM software, correct the MP2 and 3 lot numbers in the CDM software manually (as described in the CDM manual Version 4.0, chapter 5.1.4).
Alternatively, discontinue use of the CD-ROM and Bio-Rad will replace the CD-ROM when the quality issue is resolved.
This action has been closed out on 24/09/2018 |
| Contact Information |
1800 224 354 - Bio-Rad Laboratories Technical Support |