Z-0922-03

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

Name: Z-0922-03 ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
Creator: Cytyc Corporation
Published: 2003-01-29
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2003-01-29 / Terminated

FDA source

Cytyc Corporation began a recall of ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001 on 2003-01-29. The reason FDA records is "Microscope Slides contaminated with fungal material". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0922-03
Status: Terminated
Initiated: 2003-01-29
Posted: 2003-06-12
Terminated: 2003-10-22
Recalling firm: Hologic, Inc.
Product: ThinPrep Microscope Slides for Non-Gynecologic Use Size 1'' x 3'' Reorder Number: 70214-001
Product code: KEW Slides, Microscope
Reason for recall: Microscope Slides contaminated with fungal material
FDA 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 in commerce: 5,261 units
Distribution: Nationwide
Product codes and lots: Lot Numbers: 4392, 4492, 4592, 4692, 4792, 4892, 4992, 5092, 5192, 5292, and 0293

Product code KEW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)