FDA Medical Device Recalls (openFDA)
Cytyc Corporation: ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
- Recall number
- Z-0922-03
- Recalling firm
- Cytyc Corporation
- Product
- ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
- Status
- Terminated
- Initiated
- 2003-01-29
- Posted
- 2003-06-12
- Terminated
- 2003-10-22
- Reason
- Microscope Slides contaminated with fungal material
- Root 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
- 5,261 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KEW
- Firm FEI
- 1000120743
- Firm city
- Boxborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28