Recall Z-1801-2017— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2017-03-17, terminated 2022-02-16. It names one FDA 510(k) clearance: K955647. 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 total estradiol concentration in human serum or plasma (heparin).. Reason: Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-17
- Terminated
- 2022-02-16
- Firm location
- Marcy L'Etoile, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 total estradiol concentration in human serum or plasma (heparin).
Reason for recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.