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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62117

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 08, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tripath Imaging, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

PrepStain Kit: 1.2 DiTi Cone. 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.

Z-2085-2012
Recall number
Z-2085-2012
Initiated
December 08, 2011
Classification
Class II
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog # 490670: These items are not serially tracked.

Distribution pattern

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).

device · product 2 of 4

PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. 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.

Z-2086-2012
Recall number
Z-2086-2012
Initiated
December 08, 2011
Classification
Class II
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
1274 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog # 491074: Serial/Lot # 110805MA

Distribution pattern

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).

device · product 3 of 4

PrepStain Slide Processor. 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.

Z-2087-2012
Recall number
Z-2087-2012
Initiated
December 08, 2011
Classification
Class II
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
201 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog # 490100; Serial/Lot #s: USPS200576, USPS200577, USPS200578, USPS200583, USPS200584, USPS200585, USPS200586, USPS200587, USPS200588, USPS200589, USPS200590, USPS200591,USPS200592, USPS200593, USPS200594, USPS200595, USPS200596, USPS200597,USPS200598, USPS200599, USPS200600, USPS200601, USPS200602, USPS200603, USPS200604, USPS200605, USPS200606, USPS200607, USPS200608, USPS200609,USPS200610, USPS200611, USPS200612, USPS200613, USPS200614, USPS200615, USPS200616, USPS200617, USPS200618, USPS200619, USPS200620, USPS200621,USPS200622, USPS200623, USPS200624, USPS200625, USPS200626, USPS200627,USPS200628, USPS200629, USPS200630, USPS200631, USPS200632, USPS200633, USPS200634, USPS200635, USPS200636, USPS200637, USPS200638, USPS200639,USPS200640, USPS200641, USPS200642, USPS200643, USPS200644, USPS200645, USPS200646, USPS200647, USPS200648, USPS200649, USPS200650, USPS200651, USPS200652, USPS200653, USPS200654, USPS200655, USPS200656, USPS200657, USPS200658, USPS200659, USPS200660, USPS200661, USPS200662, USPS200663, USPS200664, USPS200665, USPS200666, USPS200667, USPS200668, USPS200669, USPS200670, USPS200671, USPS200672, USPS200673, USPS200674, USPS200675, USPS200676, USPS200677, USPS200678, USPS200679, USPS200680, USPS200681, USPS200682, USPS200683, USPS200684, USPS200685, USPS200686, USPS200687, USPS200688, USPS200689, USPS200690, USPS200691, USPS200692, USPS200693, USPS200694, USPS200695, USPS200696, USPS200697, USPS200698, USPS200699, USPS200701, USPS200702, USPS200703, USPS200704, USPS200705, USPS200706, USPS200707, USPS200708, USPS200709, USPS200710, USPS200711, USPS200712, USPS200713, USPS200714, USPS200715, USPS200716, USPS200717, USPS200718, USPS200719, USPS200720, USPS200721, USPS200722, USPS200723, USPS200724, USPS200725, USPS200726, USPS200727, USPS200728, USPS200729, USPS200730, USPS200731, USPS200732, USPS200733, USPS200734, USPS200735, USPS200736, USPS200737, USPS200738, USPS200739, USPS200740, USPS200741, USPS200742, USPS200743, USPS200744, USPS200746, USPS200748, USPS200751, USPS200756, USPS200757, USPS200758, USPS200759, USPS200760, USPS200761, USPS200762, USPS200763, USPS200764, USPS200765, USPS200766, USPS200767, USPS200768, USPS200769, USPS200770, USPS200771, USPS200772, USPS200773, USPS200774, USPS200775, USPS200776, USPS200777, USPS200778, USPS200781, USPS200783 and USPS200787.

Distribution pattern

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).

device · product 4 of 4

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.

Z-2088-2012
Recall number
Z-2088-2012
Initiated
December 08, 2011
Classification
Class II
Status
Terminated
Recalling firm
Tripath Imaging, Inc.
Quantity
1166 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

SAP Part numbers: 490423, 490424, 490428, 490588, 490626, 490954 and 490671.

Distribution pattern

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).