Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2331-2018 — 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 stimulatin

U.S. FDA — Device Enforcement · France · 2018-04-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2331-2018
Date of alert: 2018-04-09
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: BioMerieux SA
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 1005888210

Reported risk: Invalid calibration with low calibrator S1 while using the product.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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