The FastPack System Comlete Immunoassay Kit Immunoassay recall
The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the…
Why was The FastPack System Comlete Immunoassay Kit Immunoassay recalled?
The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.
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?
1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P
- Product
- The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the…
- Recalling firm
- Qualigen Inc
- Quantity
- 24 Kits (30 test packs each) 720 tests
- Distribution
- US Nationwide distribution in the states of AL, AK, CA, HI, and TX.
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)