Genetic Testing Institute Recalls PF4 Enhanced Assay Kits Due to Invalid Results
Genetic Testing Institute is recalling 386 lots of LIFECODES PF4 Enhanced assay kits because inconsistent values can lead to invalid test results.
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 explicitly states that the hazard (invalid assays) would not result in significant harm, fitting the criteria for a moderate severity recall involving low-risk issues or theoretical harm.
Plain-English summary
Genetic Testing Institute, Inc. is recalling 386 kits of the Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45, Lot Number 3000389. The recall was initiated because of observed inconsistent replicate values when testing the kit's Positive Control and patient samples. This variation in reactivity can lead to invalid assays.
The affected kits were distributed nationwide in the United States and internationally to Canada, China, Slovakia, and Spain. The source text notes that if an invalid assay is obtained, the results should not be reported and the test should be re-run. The recall notice states that an invalid assay would not result in significant harm to a patient.
The recalled product
- Product
- Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
- Manufacturer
- Genetic Testing Institute,inc
- 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 (1)
- Kit Lot Number 3000389
Distribution
Distributed nationwide across the United States.
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