ADVIA Centaur Enhanced Estradiol recall
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Why was ADVIA Centaur Enhanced Estradiol recalled?
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All lot numbers UDI: (01)00630414574646(10)14530079(17)20220304 (01)00630414574646(10)53553079(17)20220304 (01)00630414574646(10)54118081(17)20220521 (01)00630414574646(10)62860081(17)20220521 (01)00630414574646(10)70552083(17)20220805 (01)00630414574646(10)76807076(17)20220115 (01)00630414574646(10)93281076(17)20220115
- Product
- ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 952 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
- Recall date
- May 11, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)