Abbott Ireland Diagnostics Division
Complete recall history across all FDA and CPSC categories — 12 total recalls
Abbott Ireland Diagnostics Division 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 (12)
FDA medical device enforcement actions by Abbott Ireland Diagnostics Division
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 5, 2019 | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol a... | Patient results may be falsely elevated. This patient impact only applies to ... | Class II |
| Feb 5, 2019 | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradi... | Patient results may be falsely elevated. This patient impact only applies to ... | Class II |
| Nov 21, 2018 | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferriti... | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i TSH Reagent Kit, List Number 07P4830 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i Free T4 Reagent Kit, List Number 07P7030 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i Estradiol Reagent Kit, List Number 07P5020 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Nov 21, 2018 | Alinity i Progesterone Reagent Kit, List Number 08P3620 | Abbott has become aware of a manufacturing issue that can result in damage to... | Class II |
| Oct 12, 2018 | ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR pla... | Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show ... | Class II |
| Oct 12, 2018 | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR plat... | Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show ... | Class II |
| Sep 11, 2014 | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.... | 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 ... | 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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