Recall Z-1801-2017 ยท CHP Radioimmunoassay, Estradiol
BioMerieux SA
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).
| Date | Mar 20, 2017 (initiated Mar 17, 2017) |
| Status | Terminated |
| Reason | Fulvestrant cross reacts with the VIDAS Estradiol II immunoassay and may cause falsely elevated estradiol results in patients treated with Fulvestrant. |
| Root cause | Device Design |
| Action | 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. Fo |
| Quantity | 834 kits |
| Distribution | Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY Biomerieux Vitek, Inc., Feb 6, 1996 |