Clark Laboratories, Inc. (dba,Trinity Biotech USA)

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

Clark Laboratories, Inc. (dba,Trinity Biotech USA) 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 Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Date Product Reason Class
Nov 1, 2018 Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated hi... lack of 510K Class II
Nov 1, 2018 Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high per... lack of 510K Class II
Nov 1, 2018 Genesys Analytical Column, REF 01-05-0017 intended to be used with automated ... lack of 510K Class II
Nov 1, 2018 Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high per... lack of 510K Class II
Nov 1, 2018 ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with aut... lack of 510K Class II
Jul 11, 2016 Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ... The product lot failed to meet QC acceptance criteria during stability testin... Class III
Nov 17, 2014 Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... Through in-house routine real time stability monitoring of Trinity's Captia S... Class III
Aug 27, 2013 Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay f... Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to fals... Class II
May 29, 2012 Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code... The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has ... Class III

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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