Device recall: PrepStain Syringing Pipettes 240 (Catalog #490517)
Class III FDA enforcement event 61737. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Tripath Imaging, Inc. started this device recall on 22 Mar 2012. The firm address in the FDA record is in Burlington, NC. FDA put the recall in Class III. FDA event 61737 has 5 product records. The first FDA enforcement report date is 27 Jun 2012. The record gives the status Terminated, with the termination date 3 Dec 2012.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution.
Recalling firm
Tripath Imaging, Inc., Burlington, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1811-2012 | PrepStain Syringing Pipettes 240 (Catalog #490517) | 46,112,784 for all products in Recall Event | Class III | Terminated | 27 Jun 2012 |
| Z-1812-2012 | PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 | 46,112,784 for all products in Recall Event | Class III | Terminated | 27 Jun 2012 |
| Z-1813-2012 | PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 | 46,112,784 for all products in Recall Event | Class III | Terminated | 27 Jun 2012 |
| Z-1814-2012 | Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 | 46,112,784 for all products in Recall Event | Class III | Terminated | 27 Jun 2012 |
| Z-1815-2012 | PrepStain 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 recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240) | 46,112,784 for all products in Recall Event | Class III | Terminated | 27 Jun 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class III
- 6%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 8 Dec 2011 | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-1811-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 61737. https://recallregister.com/fda/iii/61737/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution.
- What quantity of product is in FDA event 61737?
- The event has 5 product records. The first record gives this quantity:
46,112,784 for all products in Recall Event
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 6% of the 823 device events that started in 2012 are in Class III.