FDA Device recall Z-2331-2018
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France by Biomerieux, citing invalid calibration with low calibrator S1 while using the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2331-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-09 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomerieux |
| Distribution | KY |
Product
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human follicle stimulating hormone (FSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of pituitary gland and gonadal disorders.
Reason
Invalid calibration with low calibrator S1 while using the product.
Identifiers
| code_info | Lot #1005888210 was distributed in the U.S. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2331-2018%22
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