VIDAS Estradiol II, Ref 30431-01, 60 tests recallZ-1801-2017 · BioMerieux SA · initiated Mar 17, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioMerieux SA or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
FDA root cause category: Device Design
What the company is doing
bioMerieux sent an Important Product Safety Notice A Product Safety Notice to all affected customers on March accounts on March 17, 2017, informing them not to use VIDAS Estradiol II test to test estradiol level in patients under Fulvestrant therapy. The letter did not request return of any of the product, and requested that they return an acknowledgement form acknowledging receipt of the notice and that they have followed the instructions and implemented the actions in the field notice. Customers with questions were instructed to contact their bioMerieux Customers Service representative. For questions regarding this recall call 314-731-8805.
Recall details
- Recall number
- Z-1801-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 17, 2017
- Posted by the FDA
- Mar 20, 2017
- Recalling firm
- BioMerieux SA
- Quantity
- 834 kits
- Product code
- CHP
- FDA submissions
- K955647
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
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).
Code information (models, lots, serial numbers)
Lots 1005081700, 1005172850 & 1005359170
Other devices under the same FDA submission
1 device cleared under K955647 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- VIDAS® Estradiol II 30431-01Biomerieux SA · RADIOIMMUNOASSAY, ESTRADIOL2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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