BD PrepStain System, Model Number: 799-14000-00 recallZ-1090-2009 · Bd Diagnostic Systems Tripath · initiated Sep 26, 2008
Terminated All recalls posted in March 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bd Diagnostic Systems Tripath or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results.
FDA root cause category: Software change control
What the company is doing
BD Diagnostics began contacting known non-gyn customers by phone on 09/26/2008. Customers were notified by Urgent - Important Product Information letter on 09/29/2008. They were advised to stop using the system until they complete a list of actions provided in the letter. A telephone contact number for Technical Support was provided in the letter. A permanent software based solution will be provided to customers when completed. They anticipate the software will be available in October 2008.
Recall details
- Recall number
- Z-1090-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 26, 2008
- Posted by the FDA
- Mar 19, 2009
- Recalling firm
- Bd Diagnostic Systems Tripath
- Quantity
- 662 units
- Product code
- MKQ
- FDA submissions
- P970018
- Distribution
- Worldwide Distribution
Product description
BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage.
Code information (models, lots, serial numbers)
GYN software version 1.2, Non-GYN version 2.80; GYN software version 1.3.0.1, Non-GYN software version 2.80.
Other devices under the same FDA submission
13 devices cleared under P970018 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD SurePath™ Collection Vial 491452Becton, Dickinson And Company · Processor, cervical cytology slide, automated82 reports
- BD Totalys SlidePrep 491346Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated53 reports
- BD PrepStain Slide Processor 490100Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated24 reports
- BD Totalys MultiProcessor 443327Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated13 reports
- BD PrepStain Slide Processor 490407Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated4 reports
- BD Totalys™ MultiProcessor Consumables Kit 491453Becton, Dickinson And Company · Processor, cervical cytology slide, automated4 reports
- BD PrepStain Slide Processor 490410Tripath Imaging, Inc. · Processor, Cervical Cytology Slide, Automated2 reports
- BD PrepStain Slide Processor 490104Tripath Imaging, Inc. · Processor, Cervical Cytology Slide, Automated1 report
- BD PrepMate™ Automated Accessory 491103Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated1 report
- BD SurePath™ Manual Method Kit 491266Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated1 report
- BD SurePath™ Preservative Fluid 491337Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated1 report
- BD PrepStain™ Consumables Kit 491454Becton, Dickinson And Company · Processor, cervical cytology slide, automated1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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