Phadia US Inc

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

Phadia US 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 Phadia US Inc

Date Product Reason Class
May 1, 2023 EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 1241... Higher reported results when running EliA GliadinDP IgG Well on the instrumen... Class II
May 1, 2023 Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measure... Higher reported results when running EliA GliadinDP IgG Well on the instrumen... Class II
Dec 14, 2020 EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measu... Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well... Class II
Dec 18, 2017 ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016). ImmunoC... The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not ... Class II
Dec 18, 2017 ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP ... The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. Class II
Jul 5, 2017 Phadia 1000 Instrument, Article Number 12-3800-01. The "Retry" command does not function properly which could cause a shortage o... Class II
Jan 30, 2017 EliA Sample Diluent, Article number, 83-1023-01 Erroneous EliA test results related to problems with liquid level detection a... Class II
Nov 20, 2014 Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-0... During an investigation of instrument logs it was determined that In specific... Class II
Aug 2, 2012 PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test ... Customers were not following the labeled assay procedure. This was due to a l... 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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