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Phadia Ab

Complete recall history across all FDA and CPSC categories — 5 total recalls

Phadia Ab 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 (5)

FDA medical device enforcement actions by Phadia Ab

Date Product Reason Class
May 24, 2023 EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In ... Complaints that specific samples produced false positive EliA GBM results. A ... Class II
Jul 9, 2019 Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully i... code 7-102 Liquid Sensor Error Class II
May 10, 2019 EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is in... Potential for reporting low assay results Class II
Nov 20, 2017 Phadia Prime software, article number 12-4101-00, as used in combination with... We want to inform all Phadia 250 system operators performing EliA Assays not ... Class II
Dec 28, 2015 EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is int... All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmD... 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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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