CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report
Vidas Estradiol II recalled by BioMerieux
BioMerieux is recalling Vidas Estradiol II, distributed nationwide in the US. The recall was initiated on 17 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1801-2017
- FDA event ID
- 76727
- Recalling firm
- BioMerieux, Marcy L'Etoile, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2017
- FDA classified
- 12 Apr 2017
- Reported
- 19 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Mar 2017 | Recall initiated by company | |
| 12 Apr 2017 | Classified by FDA | +26 days |
| 19 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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).
Where it was distributed
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaIowaIndianaLouisianaMichiganMississippiNorth CarolinaNew YorkOhioOklahomaOregonPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
Which lots are affected?
Lots 1005081700, 1005172850 & 1005359170
Where was it sold?
Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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