FDA Device recall Z-2166-2017
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurem…
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurem… by Siemens Healthcare Diagnostics, citing 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 2-8¿C, as published in the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-31 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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.
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 2-8¿C, 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.
Identifiers
| code_info | Lot Numbers: 1) 357, 2) 358, 3) 360, 4) 361 & 5) 363 Expiration Dates: 1) 2017-01-30, 2) 2017-03-31, 3) 2017-04-30, 4) 2017-05-31 & 5) 2017-06-30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2017%22
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