Tripath Imaging recalls

Tripath Imaging has 9 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 1 Aug 2012. The most frequent reason is packaging defects.

Total recalls9since 2012

Last 12 months0reported

Class I00% of total

Ongoing0latest 1 Aug 2012

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 44%Class III 5 56%

Why tripath imaging is recalled

Packaging Defects556%
Foreign Material444%

Product types

Other Medical Devices778%
Test Kits & Diagnostics222%

By year

20129100%

All tripath imaging recalls, newest first

9 total

Reported	Class	Recall	Company	Reason	Where
1 Aug 2012Device	CLASS II	PrepStain PM Kit, T-AG recalled by Tripath Imaging	Tripath Imaging	Foreign Material	Nationwide
1 Aug 2012Device	CLASS II	PrepStain Upgrade Kit: 3.0.3/1.2 DiTi Cone recalled by Tripath Imaging	Tripath Imaging	Foreign Material	Nationwide
1 Aug 2012Device	CLASS II	PrepStain Kit: 2 DiTi Cone recalled by Tripath Imaging	Tripath Imaging	Foreign Material	Nationwide
1 Aug 2012Device	CLASS II	PrepStain Slide Processor recalled by Tripath Imaging	Tripath Imaging	Foreign Material	Nationwide
27 Jun 2012Device	CLASS III	Manual Method 1: 480 Test Kit (PreCoat) recalled by Tripath Imaging	Tripath Imaging	Packaging Defects	NC
27 Jun 2012Device	CLASS III	PrepStain Installation Kit (PreCoat) recalled by Tripath Imaging	Tripath Imaging	Packaging Defects	NC
27 Jun 2012Device	CLASS III	PrepStain GN 480 Disposable Kit recalled by Tripath Imaging	Tripath Imaging	Packaging Defects	NC
27 Jun 2012Device	CLASS III	PrepStain Syringing Pipettes 240 recalled by Tripath Imaging	Tripath Imaging	Packaging Defects	NC
27 Jun 2012Device	CLASS III	PrepStain GYN 480 Disposable Test Kit with PreCoat Slides recalled	Tripath Imaging	Packaging Defects	NC

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.