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VITROS Immunodiagnostic Products Estradiol Reagent Pack (2016-07-15)
- Starting date:
- July 15, 2016
- Posting date:
- August 5, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-59704
Affected products
A. VITROS Immunodiagnostic Products Estradiol Reagent Pack
Reason
Ortho Clinical Diagnostics (Ortho) has initiated this recall due to the potential for medications that are derivatives of estrogen (e.g. fulvestrant, brand name: Faslodex) to interfere with estradiol immunoassays and cause positively biased sample results. Fulvestrant is an estrogen receptor antagonist medication that blocks estrogen from tumors. The drug is used in the treatment of patients with metastatic, postmenopausal, hormone receptor-positive breast cancer.
Affected products
A. VITROS Immunodiagnostic Products Estradiol Reagent Pack
Lot or serial number
1470
1490
1500
1510
1538
Model or catalog number
8552630
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS, PENCOED, BRIDGEND