Reported Apr 6, 2016 · Terminated
Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M…
Roche Diagnostics Operations, 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: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
03000079 | Estradiol II Elecsys and cobas e analyzers 190 |
| — | M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL |
| — | R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL |
| — | Mesterolone 130 ng/mL |
| — | R2 Estradiol derivative, labeled with ruthenium complex 2.75 ng/mL Product Usage: Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers. |
- Lot codes and dates
- Part Number Elecsys Estradiol II03000079190; all lot numbers are affected
- Amount recalled
- 102,312
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Due to the risk of a recently identified cross reactivity, the Elecsys Estradiol assay should not be used when monitoring patient being treated with fulvestrant. Customers should be informed that fulvestrant will increase the apparent concentration of estradiol in women being treated with this drug. If treatment with fulvestrant has been altered or discontinued as a result of falsely elevated e
This product could cause temporary or reversible health problems — stop using it.
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