Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 4, 2018
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.
Invalid calibration with low calibrator S1 while using the product.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioMerieux Sa recalled VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. … - a moderate-severity action.
VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. … was recalled by BioMerieux Sa in July 4, 2018. Reason: Invalid calibration with low calibrator S1 while using the product.. Check the official notice for the remedy. Verify recall #Z-2331-2018 with the FDA Devices before acting.
The recall
BioMerieux Sa issued this moderate-severity FDA Devices recall-Invalid calibration with low calibrator S1 while using the product..
- Moderate
- severity level
- Class II
- classification
- July 4, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2331-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2331-2018) was formally reported on July 4, 2018, with the manufacturer initiating the action on April 9, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. BioMerieux Sa is listed as the recalling firm, operating out of Marcy L'Etoile. Federal records list the affected scope as 59 units distributed to the U.S..
The documented reason for this recall is: Invalid calibration with low calibrator S1 while using the product. Distribution data in the federal record shows the product reached: Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
59 units distributed to the U.S.
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2331-2018 |
| Date reported | July 4, 2018 |
| Date initiated | April 9, 2018 |
| Recalling firm | BioMerieux Sa |
| Firm location | Marcy L'Etoile |
| Affected scope | 59 units distributed to the U.S. |
| Distribution | Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2331-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioMerieux Sa. Units affected: 59 units distributed to the U.S..
Why was this product recalled? ▼
Invalid calibration with low calibrator S1 while using the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2018. Severity: Moderate. Recall number: Z-2331-2018.
Where was the recalled product distributed? ▼
Distribution: Distribution was made to the recalling firm's distribution center in KY. There was no military/government distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2331-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 4, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.