Reported Jun 7, 2017 · Terminated
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the…
Siemens Healthcare Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics, Inc. · 511 Benedict Ave · Tarrytown, NY · 10591-5005
Is this the product you have?
- 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.
- Lot codes and dates
- Lot Numbers
1) 3572) 3583) 3604) 361 & 5) 363
- Expiration Dates
1) 2017-01-302) 2017-03-313) 2017-04-304) 2017-05-31 & 5) 2017-06-30
- Lot Numbers
- Amount recalled
- 9100 kits
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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