Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum Recalled by PerkinElmer Health Sciences, Inc. Due to A DELFIA hFSH kit lot failed real time...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact PerkinElmer Health Sciences, Inc. directly.
Affected Products
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Quantity: 79 kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 4 states: CA, CO, NY, WA
About PerkinElmer Health Sciences, Inc.
PerkinElmer Health Sciences, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report