Recall Z-2166-2017 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Siemens Healthcare Diagnostics, Inc.
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of hirsutism.
| Date | Apr 19, 2017 (initiated Jan 31, 2017) |
| Status | Terminated |
| Reason | Certain lots of Sex Hormone Binding Globulin (SHBG) do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8C, as published in the Instructions for Use (IFU). Adjustors stored at 2-8C after 14 days may show a bias in patient samples and quality control falling outside of published ranges. Lookback not recommended. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens issued an Urgent Medical Device Correction (UMDC) to customers using the affected SHBG adjustor lots. Customers were advised to store the affected reconstituted adjustor lots at 2-8C or -20C for up to 14 days, after which they must be discarded. The IMMULITE/IMMULITE 1000 SHBG is not affected by this issue. Customers with questions were instructed to contact their Siemens Customer Care Center or their local Siemens technical support representative. For questions regarding this recall call 914-631-8000. |
| Quantity | 9100 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955440 | IMMULITE SHBG (MODIFICATION) Diagnostic Products Corp., Dec 21, 1995 |