| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01164-1 |
| Product Name/Description |
IMMULITE Systems 1000 / 2000 / 2000 XPi CMV IgM Assay (used for the determination of Cytomegalovirus (CMV). An in vitro diagnostic medical device (IVD)
Immulite / Immulite 1000
Test Code: CMM
Catalogue Number: LKCM1
Siemens Material Number: 10381296
Lot Numbers: 0330 and 0331
Immulite 2000 / 2000 XPi
Test Code: CMM
Catalogue Number: L2KCM2
Siemens Material Number: 10381320
Lot Numbers: 255, 256, 257, 258, 259, 260, 261, 262, 263, 264, 266, 267
ARTG Number: 208726 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics has identified increased imprecision on some patient samples with the affected CMV IgM reagent lots identified on the IMMULITE / IMMULITE 1000 and the IMMULITE 2000 / IMMULITE 2000 XPi Systems. These samples may exhibit higher percent coefficient of variation (% CV) than the precision performance data published in the Instructions For Use (IFU) across nonreactive, indeterminate, and reactive ratios.
Quality controls provided in the CMV IgM kit may not detect the imprecision with patient results. Siemens is continuing to investigate the cause of the imprecision.
The risk to health is remote and limited to a falsely nonreactive result when truly indeterminate or reactive, which may lead to delayed investigation of acute CMV infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to discontinue use and discard the affected batches, and recommends transitioning to IMMULITE/IMMULITE 1000 kit lot 0332 and above and IMMULITE 2000/2000 XPi CMV IgM kit lots 268 and above.
Siemens is recommending a look back, including retesting of existing samples provided specimens meet time and storage conditions specified in the Instructions for Use, for previously generated nonreactive results of =0.40 and <0.9. Retesting using CMV IgM or another appropriate CMV test, depending on the clinical context and timing of the initial test, may be considered.
This action has been closed out on the 25/09/2018. |
| Contact Information |
1800 310 300 - Siemens Technical Support Centre |