| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00293-1 |
| Product Name/Description |
cobas 8000 modular analyser series, control unit software version 03-03 (An in vitro diagnostic medical device (IVD))
Affected Elecsys assays and their catalogue numbers:
CA 15-3 II (03045838122)
CMV IgM (04784618190)
Anti-HAV IgM (11820591122)
Anti-HBc IgM (11820567122)
Rubella IgM (04618831190)
Toxo IgM (04618858190)
CMV IgG Avidity (05909708190)
Cortisol (11875116122)
Estradiol II (03000079190)
N-MID Osteocalcin (12149133122)
Toxo IgG (04618815190) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
When using the automatic dilution function on cobas e 602, a software bug occurs leading to an incorrect diluent being used during operation on certain Elecsys assays. This happens when all three of the following conditions are present concurrently:
- A total of > 2000 reagents kits or diluents had been registered on the cobas e 602 modules within one configuration; and
- Two or more different diluent types are available on board on the instrument (eg. Diluent Universal and Diluent MultiAssay); and
- A previous diluent (eg Diluent Universal) had been registered in the database with the identical key information has the current diluent of a different type (eg Diluent Multiassay). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is providing work around instructions and a software correction is being developed. |
| Contact Information |
02 9860 2329 - Roche Diagnostics Australia |