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Leica Biosystems Richmond Inc.

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

Leica Biosystems Richmond 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 Leica Biosystems Richmond Inc.

Date Product Reason Class
Jul 14, 2017 Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, R... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intende... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is int... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody i... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is in... A delay in transit may have contributed to nonconformity as the product was s... Class II
Jul 14, 2017 Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is inte... A delay in transit may have contributed to nonconformity as the product was s... Class II
May 6, 2016 Ariol is an automated scanning microscope and image analysis system. It is in... An issue during the manufacturing process caused systems to have an improperl... Class III
May 2, 2016 CytoVision Image Analysis and Capture System, an automated cell-locating devi... Systems have an improperly activated Windows 7 OS, even though a valid Window... 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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