Gen-Probe LIFECODES PF4 Enhanced assay recall
Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA).
Why was Gen-Probe LIFECODES PF4 Enhanced assay recalled?
Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Kit Lot Number 3000389
- 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).
- Recalling firm
- Genetic Testing Institute,inc
- Quantity
- 386 kits (370 US, 16 OUS)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, China, Slovakia, and Spain.
- Recall date
- April 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)