MAUDE Adverse Event Report: HOLOGIC, INC THINPREP¿ CYTOLYT® SOLUTION

Catalog Number	0236004
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal investigation performed by manufacturer: returned material: the complainant did not return the allegedly defective material for evaluation.The investigation was performed on manufacturing retained material.Method: since the complainant did not return the reported bottle, the investigation relied on retained product evaluation.Hologic scientific product support (sps) evaluated retained, unopened samples from lot 5062ec using the following method: 1.Invert the bottle, cup, or tube three to five times to homogenize the solution.2.Pour a 20 ml aliquot directly into a clean empty thinprep vial.Label and cap the vial.3.Process the vial to prepare a slide using a thinprep 5000 processor with the nongyn sequence, thinprep nongyn filters, and thinprep slides.4.Stain the slides per fixation and staining procedure.Coverslip the slides using an approved method.5.Review the slides for the presence of any contaminant using standard light microscopy with 10x ocular lenses and 10x, 20x, and 60x objective lenses.Findings: on september 2, 2025, sps identified a fungal appearing contaminant on a slide prepared from the retained quart from lot 5062ec.Sps performed additional retain testing across all unexpired lots of cytolyt quart, cup, and tube configurations in distribution.All lots other than 5062ec met appearance specifications and were free of contamination.On october 19, 2025, microbac laboratories identified the organism as parengyodontium album using dna sequencing technology.On november 10, 2025, sps completed the full retain review confirming that only lot 5062ec exhibited visible fungal contamination.Conclusion: the investigation confirmed microbial contamination in one retained, unopened bottle of thinprep cytolyt solution lot 5062ec.No other lots were affected.Per risk assessment the overall probability of occurrence of harm is improbable.No adverse events, misdiagnoses, or patient harms have been reported.Although the clinical risk is low, the product does not conform to its labeling and represents a gmp nonconformance.As such, lot 5062ec has been recalled from the field.
Event or Problem Description
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.

• Brand Name: THINPREP¿ CYTOLYT® SOLUTION
• Common Device Name: CYTOLYT
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough 01752
• Manufacturer Contact: caroline bartlett
• MDR Report Key: 23643897
• Report Number: 1222780-2025-00601
• Device Sequence Number: 10160684
• Product Code: LEA
• UDI-Device Identifier: 25420045508405
• UDI-Public: (01)25420045508405(17)270303(10)5062EC
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0236004
• Device Lot Number: 5062EC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1000120743/09022025/R000
• Patient Sequence Number: 1
• Patient Sex: Unknown