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U.S. Department of Health and Human Services

Class 3 Device Recall Cytyc ThinPrep

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  Class 3 Device Recall Cytyc ThinPrep see related information
Date Initiated by Firm January 29, 2003
Date Posted June 12, 2003
Recall Status1 Terminated 3 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
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 2		 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.
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