BioMerieux Recalls VIDAS Estradiol II Assay Due to Fulvestrant Cross-Reactivity
BioMerieux SA is recalling VIDAS Estradiol II kits because Fulvestrant treatment can cause falsely elevated estradiol results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (falsely elevated diagnostic results) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioMerieux SA is recalling 834 kits of the VIDAS Estradiol II assay (Ref 30431-01, 60 tests). The affected lots are 1005081700, 1005172850, and 1005359170. These kits were distributed nationwide, including in Arizona, California, Colorado, Florida, Georgia, Indiana, Iowa, Louisiana, Michigan, Mississippi, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, and Washington.
The recall is due to cross-reactivity with the drug Fulvestrant. Patients treated with Fulvestrant may experience falsely elevated estradiol results when using this specific immunoassay. The VIDAS Estradiol II assay is intended for use on VITEK ImmunoDiagnostic Assay System instruments to determine total estradiol concentration in human serum or plasma.
Healthcare facilities and laboratories should stop using the affected kits and contact BioMerieux SA for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of tota
- Manufacturer
- BioMerieux SA
- Affected units
- 834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots 1005081700
- 1005172850 & 1005359170
Distribution
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