Abbott Ireland Diagnostics Division
Medical device manufacturer in Longsford, IE.
8510(k) clearances
0PMA approvals
12recalls
Device types
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CJW Bromcresol Purple Dye-Binding, Albumin 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- JFJ Catalytic Methods, Amylase 1
- CDQ Urease And Glutamic Dehydrogenase, Urea… 1
- CHH Enzymatic Esterase--Oxidase, Cholesterol 1
- CIG Diazo Colorimetry, Bilirubin 1
- CJE Nitrophenylphosphate, Alkaline Phosphatase… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K223317 | Alkaline Phosphatase2CJE · Traditional | 07/21/2023SE |
| K223324 | Total Bilirubin2CIG · Traditional | 12/29/2022SE |
| K203597 | Cholesterol2CHH · Traditional | 06/30/2022SE |
| K203771 | Urea Nitrogen2CDQ · Traditional | 05/31/2022SE |
| K210633 | Amylase2JFJ · Traditional | 05/26/2022SE |
| K210452 | Creatinine2CGX · Traditional | 03/22/2022SE |
| K203530 | Albumin BCP2CJW · Traditional | 03/18/2022SE |
| K203248 | Albumin BCG2CIX · Traditional | 11/23/2021SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1354-2019 Class II | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a…Patient results may be falsely elevated. This patient impact only applies to patients currently being… | 02/05/2019Terminated |
| Z-1353-2019 Class II | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is…Patient results may be falsely elevated. This patient impact only applies to patients currently being… | 02/05/2019Terminated |
| Z-2208-2019 Class II | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a…Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0669-2019 Class II | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0668-2019 Class II | Alinity i Progesterone Reagent Kit, List Number 08P3620Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0667-2019 Class II | Alinity i Estradiol Reagent Kit, List Number 07P5020Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0666-2019 Class II | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0665-2019 Class II | Alinity i Free T4 Reagent Kit, List Number 07P7030Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0664-2019 Class II | Alinity i TSH Reagent Kit, List Number 07P4830Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the… | 11/21/2018Terminated |
| Z-0799-2019 Class II | ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms…Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a… | 10/12/2018Terminated |
| Z-0798-2019 Class II | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms…Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a… | 10/12/2018Terminated |
| Z-0474-2015 Class II | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL)…17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower… | 09/11/2014Terminated |