SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the qu
FDA device recall Z-2166-2017 · posted 2017-04-19 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CDZ
- Quantity affected
- 9100 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2017-01-31
- Date posted
- 2017-04-19
- Date terminated
- 2018-05-24
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE SHBG (MODIFICATION) (K955440) | Diagnostic Products Corp. | 1995-12-21 |