Class 3 Device Recall Cytyc ThinPrep

• Date Initiated by Firm: January 29, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on October 22, 2003
• Recall Number: Z-0922-03
• Recall Event ID: 25529
• Product Classification: Slides, Microscope - Product Code KEW
• Product: ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
• Code Information: Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293
• FEI Number: 1000120743
• Recalling Firm/ Manufacturer: Cytyc Corporation; 85 Swanson Road; Boxborough MA 01719
• For Additional Information Contact: Dan Brasco; 978-266-3103
• Manufacturer Reason for Recall: Microscope Slides contaminated with fungal material
• FDA Determined Cause: Other
• Action: On 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.
• Quantity in Commerce: 5,261 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.