ClearanceBrief
Recall Z-0922-03 ยท KEW Slides, Microscope

Cytyc Corporation

ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001

DateJun 12, 2003 (initiated Jan 29, 2003)
StatusTerminated
ReasonMicroscope Slides contaminated with fungal material
Root causeOther
ActionOn 1/29/03 the firm issued a letter advising users of the problem and requesting they cease using the slides for preparation of non-gynecological cytology specimens. Replacement product has been shipped.
Quantity5,261 units
DistributionNationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.