| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01103-1 |
| Product Name/Description |
ADVIA Chemistry Triglyceride Concentrated (TRIG_c) Reagent. An in vitro diagnostic medical device (IVD)
Catalogue Number: 10697575
Lot Numbers: 365096, 379597, 379919, 379930, 379942, 379946, 376894
ARTG Number:176642 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/08/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions for Use (IFU) linearity claim at the upper limit of the assay range as it approaches the end of its shelf life. Internal testing indicates that a patient bias (-7% to -12%) may be seen at concentration levels from 6.22 to 6.78 mmol/L. Linearity is reduced by approximately 50% at Triglyceride concentrations approaching the upper end of the extended range of 12.43 mmol/L.
Quality Control (QC) material may not detect this issue depending on the Triglyceride concentrations in the QC material.
Siemens internal testing has confirmed all other in date lots are currently meeting linearity IFU claims. However, as a precaution, until root cause is determined, a short term mitigation of reducing the expiration date to 6 months for all lots of ADVIA Chemistry Systems Triglyceride Concentrated has been implemented. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users to discontinue use and discard any remaining stock of lots 365096 and 379597.
Discontinue use and discard remaining lots once they reach the revised shelf life. Customers will need to manually monitor the revised expiration dates for the impacted lots. A review of previously generated results is at the discretion on the Laboratory Director.
This action has been closed out on 17/12/2020 |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |