Recall Z-2166-2017
Siemens Healthcare Diagnostics, Inc. · initiated January 31, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-2166-2017
- Initiated
- January 31, 2017
- Posted by FDA
- April 19, 2017
- Terminated
- May 24, 2018
- Product code
- CDZ – Radioimmunoassay, Testosterones And Dihydrotestosterone
- Quantity
- 9100 kits
- Distribution
- Nationwide Distribution
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Tarrytown, NY