DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0779-2017.
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0779-2017.
Recall terminated by FDA.
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0779-2017.
PerkinElmer Health Sciences, Inc.
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Perkinelmer Health Sciences, Inc. Recall FAQ
Perkinelmer Health Sciences, Inc. is the subject of a diagnostic devices safety report: DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum. The notice was published on November 16, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 79 units are potentially affected.