Recall Z-1093-2026 ยท LEA Preservative, Cytological
Hologic, Inc
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
| Date | Jan 15, 2026 (initiated Dec 12, 2025) |
| Status | Open, Classified |
| Reason | Fungal contamination of affected lot with Parengyodontium album. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL NOTIFICATION was mailed to consignees on 12/12/25. The notification informs consignees that Hologic will provide replacement bottles of ThinPrep CytoLyt Solution to affected customers from unaffected lots based on retained sample testing. Consignees are asked to inspect their inventory for affected product and discontinue use immediately. Affected product is to be quarantined and destroyed per routine laboratory disposal procedures. Consignees are asked to complete the Customer Response Form using the provided QR Code and Hologic will coordinate replacement. Con |
| Quantity | 3,728 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.