Z-2088-2012Class II

PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM...

Name: Z-2088-2012 PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM...
Creator: Tripath Imaging, Inc.
Published: 2011-12-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2011-12-08 / Terminated / root cause: manufacturing process

FDA source

Tripath Imaging, Inc. began a recall of PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP... on 2011-12-08. FDA classified it as Class II and gives the reason as "Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2088-2012
Classification: Class II
Status: Terminated
Initiated: 2011-12-08
Posted: 2012-07-26
Terminated: 2013-11-08
Recalling firm: Becton Dickinson & Co
Product: PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (490423); PrepStain Prep Only PM Kit, T-US (Catalog 490429); PrepStain PM Kit, T-US (Catalog 490626); PrepStain PM Kit Europe, T-US (Catalog 490428). The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytology Diagnoses. The 1.2 DiTi is the tip on the PrepStain to which a pipette tip attaches and dispenses patient samples onto a glass microscope slide.
Product code: MKQ Processor, Cervical Cytology Slide, Automated
Reason for recall: Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostics sent a letter dated March 2012 to all affected customers. The letter identifies the product, problem and actions that will be taken by the firm. Contact BD Diagnostics Technical Support at 1-877-822-7771, option 2 for questions regarding this letter.
Quantity in commerce: 1166 units
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the states AL, AK, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WY, and WV and the countries of Belgium, Brazil, Canada, China, Columbia, Hong Kong, India, Japan, Korea, Peru, Singapore, Taiwan and Victoria (Australia).
Product codes and lots: SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2088-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26
Z-2086-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26
Z-2087-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26
Z-2088-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-26

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)