| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00946-1 |
| Product Name/Description |
Atellica CH Reaction Ring Cuvette Segment. An in vitro diagnostic medical device (IVD).
Material Number: 11099326
UDI: 00630414596143
Lot Numbers: All lots starting with “N15” or “15”
ARTG 174700
(Siemens Healthcare Pty Ltd- General laboratoryware IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/10/2024 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthineers is conducting a recall after identifying a potential for imprecision with seven (7) assays having optical sensitivity when using a subset of lots of Atellica CH Reaction Ring Cuvette Segments on some Atellica CH analyser.
The lot numbers impacted of Atellica CH Reaction Ring Cuvette Segments begin with “N15” on the packaging or “15” on the underside of the cuvette segment.
Not all Atellica CH analysers are impacted by this problem.
This non-compliance does not impact Atellica CH Reaction Ring Cuvette Segments which have lot numbers that begin with “11”. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
- Carefully review the customer letter with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Inspect their current Atellica CH Reaction Ring Cuvette Segment stock.
All Atellica CH Reaction Ring Cuvette Segments beginning with “11” are not part of this communication and can be used without restriction.
Any other lot must be immediately discarded.
- Perform the instructions to assess, inspect and/or replace Atellica CH Reaction Ring Cuvettes Segments provided in the Appendix section.
- Request no-charge replacement product from their local Siemens Healthineers or distributor office. |
| Contact Information |
1800 310 300 - Siemens Customer Care Center |