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.
What this means for you
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
Related recalls
Same manufacturer · PerkinElmer Health Sciences, Inc.
See all →- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2020-06-10
- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2017-08-02
- LowPerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
- LowPerkinElmer AutoDELFIA System Recalled for Potential Plate Loading Failures
FDA (Devices) · 2017-02-01
- ModeratePerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
FDA (Devices) · 2017-02-01
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02