Manufacturer

Tripath Imaging, Inc.

9 recalls in our database name Tripath Imaging, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 0
Most recent: 2012-08-01

Of the 9 recalls from Tripath Imaging, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

ModerateFDA (Devices)·Z-2086-2012·2012-08-01
Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2088-2012·2012-08-01
Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.
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 (49042
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2085-2012·2012-08-01
Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions
Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.
Product
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 ot
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2087-2012·2012-08-01
Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions
Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1811-2012·2012-06-27
Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.
Product
PrepStain Syringing Pipettes 240 (Catalog #490517)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1812-2012·2012-06-27
Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes
Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.
Product
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1813-2012·2012-06-27
Tripath PrepStain Installation Kit Recalled for Leaking Pipettes
Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.
Product
PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1814-2012·2012-06-27
Tripath Imaging Recalls 480 Test Kits Due to Leaking Pipettes
Tripath Imaging is recalling Manual Method 1: 480 Test Kits because the PrepStain Syringing Pipettes may leak and fail to dispense the minimum required volume.
Product
Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1815-2012·2012-06-27
Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.
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)
Category
Medical Device
Distribution
0 states