PerkinElmer Recalls DELFIA hCG Kits Due to Measurement Inaccuracy
PerkinElmer is recalling 31 DELFIA hCG Kits because hCG concentrations may be decreased by 15-20% at the lower measuring range.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or significant injuries, fitting the 'Moderate' criteria for minor labeling or low-risk issues without reported harm.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling 31 DELFIA hCG Kits, an in vitro diagnostic used for the quantitative determination of human gonadotropin (hCG) in serum. The recall is due to a defect where hCG analyte concentrations may be decreased by 15-20% at the lower measuring range of hCG concentrations.
The affected kits were distributed worldwide, including nationwide in the United States and in Austria, Bolivia, the UK, Switzerland, and Thailand. The specific lot numbers involved are 664891, 666471, and 666604. Pack lot numbers are 1066489101, 106647101, and 1066660401.
Healthcare facilities and laboratories should stop using these kits and contact PerkinElmer for instructions on return or replacement. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
- Hazard
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 (4)
- Kit Lot Numbers: 664891
- 666471
- 666604 Pack Lot Numbers: 1066489101
- 1066647101
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by PerkinElmer Life and Analytical Sciences, Wallac, OY under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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