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ThinPrep®
Hologic, Inc. · Model ThinPrep® PreservCyt® Sol'n 20ml · UDI-DI 15420045508316
LEA
Prescription
4
510(k) clearances
23
Adverse events
4
Recalls
24
Facilities
Description
For use with the ThinPrep® system to preserve non-gynecological specimens.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | Hologic, Inc | Fungal contamination of affected lot with Parengyodontium album. |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o |
| 2015-04-29 | Richard-Allan Scientific Company | Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots o |
| 2012-02-20 | Leica Biosystems Richmond Inc. | Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 whic |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.