PerkinElmer AutoDELFIA hCG Kit Recalled for Inaccurate Low-Range Results
PerkinElmer is recalling AutoDELFIA 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, and the hazard involves potential inaccuracy in diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
PerkinElmer Life and Analytical Sciences, Wallac, OY is recalling the AutoDELFIA hCG Kit, an in vitro diagnostic used for the quantitative determination of human gonadotropin (hCG). The recall involves 304 kits distributed in the United States and worldwide, including Austria, Bolivia, the UK, Switzerland, and Thailand.
The recall was initiated because hCG analyte concentrations may be decreased by 15-20% at the lower measuring range of hCG concentrations. This inaccuracy could affect the reliability of test results in that specific range.
Healthcare facilities and laboratories that have received these kits should stop using them and contact PerkinElmer for further instructions. The affected kit lot number is 664303, with pack lot numbers 1066430301 and 1066430302.
The recalled product
- Product
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
- Hazard
- Affected units
- 304
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 (2)
- Kit Lot Numbers: 664303 Pack Lot Numbers: 1066430301
- 1066430302 UDI: (01)06438147009343(17)190430(10)664303
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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