Cell wash solution recalled over fungal contamination of an affected lot
Hologic is recalling 3,728 units of ThinPrep CytoLyt Solution over fungal contamination of the affected lot with Parengyodontium album.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states fungal contamination of a laboratory solution, and no injuries are reported.
Plain-English summary
ThinPrep CytoLyt Solution, a buffered cell wash solution, catalog number 0236004, is being recalled by Hologic, Inc.
The reason given in the enforcement record is fungal contamination of the affected lot with Parengyodontium album.
The record lists 3,728 units carrying UDI-DI 25420045508405, from the lot recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Laboratories should quarantine the affected lot and follow Hologic's instructions.
The recalled product
- Product
- ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
- Manufacturer
- Hologic, Inc
- Hazard
- fungal-contamination
- cytology
- reagent
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)
- Catalog number: 0236004
- UDI: (01)25420045508405(17)270303(10)5062EC
- UDI-DI: 25420045508405
- Lot number: 5062EC.
Distribution
Distributed nationwide across the United States.
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