SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro recall
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG…
Why was SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 9100 kits
- Distribution
- Nationwide Distribution
- Recall date
- June 7, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)