| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00702-1 |
| Product Name/Description |
RAPIDQC Complete Quality Control Material (QC reagent for use with blood gas instruments). An in vitro diagnostic medical device (IVD).
Lot Number 362303
ARTG Number: 185171 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
There is an error in the Expected Values Chart pertaining to the Level 2 pH control range for all Siemens blood gas instruments. Due to this error, the recovery of pH for RAPIDQC Complete, Level 2, lot number 362303, is elevated. It is also possible that some instruments may, on occasion, recover pH out of range high. However, the published target ranges for all other analytes are unaffected. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is providing their customers with the correct pH range assignments (in pH and H+ units) and corresponding barcodes for all the Siemens blood gas systems. End users are requested to re-enter the corrected pH target ranges, or rescan these barcodes into the blood gas system to replace the ones in the Expected Values Chart and keep this notice with the control material.
Repeat testing of any patient samples is at the discretion of laboratory. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |