Z-2331-2018 Class II Terminated
FDA device recall Z-2331-2018 was initiated by BioMerieux SA on Apr 9, 2018 and is designated Class II. Reason for recall: Invalid calibration with low calibrator S1 while using the product. The recall status is terminated (terminated Dec 2, 2025). Affected quantity: 59 units distributed to the U.S.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 4, 2018
- Initiation Date
- Apr 9, 2018
- Termination Date
- Dec 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units distributed to the U.S.
Product Description
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 for Recall
Invalid calibration with low calibrator S1 while using the product.
Distribution Pattern
Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
Code Information
Lot #1005888210 was distributed in the U.S.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2331-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026