PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 recallZ-1813-2012 · Tripath Imaging, Inc. · initiated Mar 22, 2012
Class III Terminated All recalls posted in June 2012
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 Tripath Imaging, Inc. 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
The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes
FDA root cause category: Component design/selection
What the company is doing
BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.
Recall details
- Recall number
- Z-1813-2012
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Mar 22, 2012
- Posted by the FDA
- Jun 15, 2012
- Recalling firm
- Tripath Imaging, Inc.
- Quantity
- 46,112,784 for all products in Recall Event
- Product code
- MKQ
- FDA submissions
- P970018
- Distribution
- Worldwide Distribution.
Product description
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Code information (models, lots, serial numbers)
100917ry, 101105sh, 110107rg
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
Other products in the same recall event
The FDA groups related products into one recall event (event 61737).
- Z-1811-2012 · TerminatedPrepStain Syringing Pipettes 240 (Catalog #490517)
- Z-1812-2012 · TerminatedPrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
- Z-1814-2012 · TerminatedManual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
- Z-1815-2012 · TerminatedPrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recal…
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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