Z-1815-2012Class III

PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that...

Name: Z-1815-2012 PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that...
Creator: Tripath Imaging, Inc.
Published: 2012-03-22
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-03-22 / Terminated / root cause: design

FDA source

Tripath Imaging, Inc. began a recall of 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... on 2012-03-22. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1815-2012
Classification: Class III
Status: Terminated
Initiated: 2012-03-22
Posted: 2012-06-15
Terminated: 2012-12-03
Recalling firm: Becton Dickinson & Co
Product: 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)
Product code: MKQ Processor, Cervical Cytology Slide, Automated
Reason for recall: 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
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 46,112,784 for all products in Recall Event
Distribution: Worldwide Distribution.
Product codes and lots: This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n, 101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c, 101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b, 110128i, 110203i, 110210r

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1815-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1811-2012	Class III	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15
Z-1812-2012	Class III	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15
Z-1813-2012	Class III	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15
Z-1814-2012	Class III	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15
Z-1815-2012	Class III	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-15

Product code MKQ

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)