VIDAS Estradiol II, Ref 30431-01, 60 tests The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments o
FDA device recall Z-1801-2017 · posted 2017-03-20 · Terminated
Recall details
- Recalling firm
- BioMerieux SA
- Reason for recall
- Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CHP
- Quantity affected
- 834 kits
- Distribution
- Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
- Date initiated
- 2017-03-17
- Date posted
- 2017-03-20
- Date terminated
- 2022-02-16
- Location
- Marcy L'Etoile, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIDAS ESTRADIOL II (E2II) ASSAY (K955647) | Biomerieux Vitek, Inc. | 1996-02-06 |