PerkinElmer Recalls DELFIA hFSH Kits Due to Stability Testing Failures
PerkinElmer Health Sciences is recalling 79 DELFIA hFSH kits because real-time stability testing showed decreased hFSH concentrations in control sera.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text describes a stability testing failure resulting in measurement bias but does not report any illnesses, injuries, or deaths.
Plain-English summary
PerkinElmer Health Sciences, Inc. is recalling 79 kits of the DELFIA hFSH kit, an in vitro diagnostic used to determine hFSH in serum. The recall involves Lot Number 646091. The kits were distributed in California, Colorado, New York, and Washington, as well as in Austria, Bolivia, Bosnia, Sweden, Norway, the Netherlands, Japan, and Great Britain.
The recall was initiated because the specific lot failed real-time stability testing. The stability data demonstrated a decrease in hFSH concentrations between -4.8% and -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in serum samples within the range of 1.76 to 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of the affected kits.
The recalled product
- Product
- DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
- Manufacturer
- PerkinElmer Health Sciences, Inc.
- Affected units
- 79
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 646091
Distribution
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