Tripath Imaging, Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Tripath Imaging, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Tripath Imaging, Inc.

Date Product Reason Class
Mar 22, 2012 Manual Method 1: 480 Test Kit (PreCoat), Catalog/Model # 490529 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 m... Class III
Mar 22, 2012 PrepStain Installation Kit (PreCoat), Catalog/Model # 490528 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 m... Class III
Mar 22, 2012 PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit,... The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 m... Class III
Mar 22, 2012 PrepStain Syringing Pipettes 240 (Catalog #490517) The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 m... Class III
Mar 22, 2012 PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523 The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 m... Class III
Dec 8, 2011 PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the Pre... Class II
Dec 8, 2011 PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a li... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the Pre... Class II
Dec 8, 2011 PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin ... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the Pre... Class II
Dec 8, 2011 PrepStain Slide Processor. The PrepStain System is a liquid-based thin lay... Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the Pre... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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