| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00215-1 |
| Product Name/Description |
Cobas e 801 Analytical Unit. An in vitro diagnostic medical device (IVD)
Material Number: 07682913001
Serial Numbers: 1601-01 to 18E6-10
Affected Part: Plunger (798-3203)
ARTG Number: 173887
(Roche Diagnostics Australia - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Roche has identified an issue with the syringe plunger on the cobas e 801 analytical unit PreWash (PW) syringe assembly. This issue may also occur on the instrument’s R1 or R2 reagent syringe assembly.
Investigations by the manufacturer have determined that depending on the affected syringe, R1, R2 or PreWash liquids may not be pipetted correctly.
In the worst case scenario during the cobas e 801 analytical unit initialisation steps, the plunger may crack leading to an impaired syringe function. This may affect the pipetting as follows:
- If the Prewash syringe plunger is broken, the cobas e 801 module cannot detect it and no alarm is issued. In this instance, the prewash step required by most assays will not be performed and an impact on measurement results cannot be excluded.
- If the R1 or R2 syringe plunger is broken, a system alarm "345-1 Warning Abnormal Low Signal" is generated and data alarm ( |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Roche Diagnostics has contacted affected sites and arranged for the installation of a hardware modification kit which ensures correct positioning and movement of the syringe plungers to prevent the issue from occurring.
This action has been closed out on 24/10/2018 |
| Contact Information |
02 9860 2357 - Customer Service Support |