VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the… recallZ-2331-2018 · BioMerieux SA · initiated Apr 9, 2018
Class II Terminated All recalls posted in June 2018
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
Invalid calibration with low calibrator S1 while using the product.
FDA root cause category: Under Investigation by firm
What the company is doing
The recalling firm issued letters to the end users dated April 2018, via FedEx 2 Day Express explaining the issue, potential risk to health, and requested the impacted lots be destroyed. For further questions, please call (314) 731-8805.
Recall details
- Recall number
- Z-2331-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 9, 2018
- Posted by the FDA
- Jun 29, 2018
- Recalling firm
- BioMerieux SA
- Quantity
- 59 units distributed to the U.S.
- Product code
- CGJ
- FDA submissions
- K921746
- Distribution
- Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.
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.
Code information (models, lots, serial numbers)
Lot #1005888210 was distributed in the U.S.
Other devices under the same FDA submission
1 device cleared under K921746 — 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® FSH 30407-01Biomerieux SA · RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE1 recall0 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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