Z-2166-2017 Class II Terminated
FDA device recall Z-2166-2017 was initiated by Siemens Healthcare Diagnostics, Inc. on January 31, 2017 and is designated Class II. 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 2-8¿C, as published in the Instructions for Use … The recall status is terminated (terminated May 24, 2018). Affected quantity: 9100 kits.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- January 31, 2017
- Termination Date
- May 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9100 kits
Product Description
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 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 2-8¿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.
Distribution Pattern
Nationwide Distribution
Code Information
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