Device recall: Alinity i TSH Reagent Kit, List Number 07P4830
Class II FDA enforcement event 81632. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Abbott Ireland Diagnostics Division started this device recall on 21 Nov 2018. The firm address in the FDA record is in Co. Longford. FDA put the recall in Class II. FDA event 81632 has 6 product records. The first FDA enforcement report date is 2 Jan 2019. The record gives the status Terminated, with the termination date 1 Apr 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
AR, FL, GA, MD, OK, VA
Recalling firm
Abbott Ireland Diagnostics Division, Co. Longford, Ireland.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0664-2019 | Alinity i TSH Reagent Kit, List Number 07P4830 | 678 units | Class II | Terminated | 2 Jan 2019 |
| Z-0665-2019 | Alinity i Free T4 Reagent Kit, List Number 07P7030 | 294 units | Class II | Terminated | 2 Jan 2019 |
| Z-0666-2019 | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 | 27 units | Class II | Terminated | 2 Jan 2019 |
| Z-0667-2019 | Alinity i Estradiol Reagent Kit, List Number 07P5020 | 79 units | Class II | Terminated | 2 Jan 2019 |
| Z-0668-2019 | Alinity i Progesterone Reagent Kit, List Number 08P3620 | 157 units | Class II | Terminated | 2 Jan 2019 |
| Z-0669-2019 | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 | 760 units | Class II | Terminated | 2 Jan 2019 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 6Median of the firm: 2
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 5 Feb 2019 | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticl | Device | Class II | 2 |
| 21 Nov 2018 | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle imm | Device | Class II | 1 |
| 12 Oct 2018 | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminesce | Device | Class II | 2 |
| 11 Sep 2014 | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparti | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0664-2019The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 81632. https://recallregister.com/fda/ii/81632/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
AR, FL, GA, MD, OK, VA
- What quantity of product is in FDA event 81632?
- The event has 6 product records. The first record gives this quantity:
678 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.