FDA Device Intelligence
Home › Hologic, Inc. › ThinPrep

ThinPrep

Hologic, Inc. · Model ThinPrep® Stain Bluing Solution, 4 L · UDI-DI 15420045509702

HZJ Prescription
10
510(k) clearances
0
Adverse events
2
Recalls
30
Facilities

Description

For cytologic staining with the ThinPrep® system.

Recalls

DateFirmReason
2015-02-19Richard-Allan Scientific CompanyThe case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and
2002-12-13EMD Chemicals IncDifficulty in reading slides due to the stain is much greener than normal.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.