ThinPrep® ThinPrep® CytoLyt® Sol'n 946mlRecalls & reported problems
Hologic, Inc. · CytoLyt® Solution for use as a cell wash and transport buffer. · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045508408), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Dec 12, 2025Open, Classified
Fungal contamination of affected lot with Parengyodontium album.
Z-1093-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Contamination; Contamination
HOLOGIC SCIENTIFIC PRODUCT SUPPORT (SPS) IDENTIFIED A FUNGAL CONTAMINANT ON A SLIDE PREPARED FROM THE RETAINED QUART OF THINPREP CYTOLYT SOLUTION (QUART CONFIGURATION, LOT 5062EC) FOLLOWING A COMPLAINT FROM A CUSTOMER IN THE UNITED STATES REGARDING FUNGAL-APPEARING MATERIAL IN THE SAME LOT. DNA SEQUENCING SUBSEQUENTLY IDENTIFIED THE ORGANISM AS PARENGYODONTIUM ALBUM, AN ENVIRONMENTAL FUNGUS AND RARE OPPORTUNISTIC PATHOGEN. NO ADVERSE EVENTS, MISDIAGNOSES, OR PATIENT HARM HAVE BEEN REPORTED; HOWEVER, OUT OF AN ABUNDANCE OF CAUTION, HOLOGIC IS SUBMITTING THIS MDR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23643897 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.