| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00491-1 |
| Product Name/Description |
Insulin-Like Growth Factor I (IGF-I) Assay (Used on Immulite and Immulite 1000 Systems). An in vitro diagnostic medical device (IVD)
Catalogue Number: LKGF1
Siemens Material Number (SMN): 10381403
Lot Number: 411
ARTG Number: 179720
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified that it takes 24 minutes of incubation prior to processing the samples on the IMMULITE/
IMMULITE 1000 system for the patient sample and the pre-treatment solution to reach full equilibration when using pre-treatment solution (LGFA) lot 055 contained in IGF-I Kit lot 411. If patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. If the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed.Quality Controls (QC) will not detect this issue.
There is the potential for a falsely depressed IGF-I value to delay the diagnosis of acromegaly and/or delay potential pharmacologic treatment to normalise serum IGF-I. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Siemens is advising users that the affected lot can continue to be used, however users should ensure the pre-treatment solution is allowed to incubate with the patient samples for a minimum of 24 minutes prior to processing.
A review of previously generated results is at the discretion of the laboratory. This action has been closed out on 14 June 2017. |
| Contact Information |
1800 310 300 - Siemens Technical Solutions Centre |