Device manufacturer, as written on reports

Abbott Ireland Diagnostics Division: medical device reports filed with FDA

2,785 reports name it as the manufacturer of the device involved, 2019–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,785
reports naming it as manufacturer: 0% of all MAUDE reports; 878
reports, 12 months to August 2026: 819 in the 12 months before; 98%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

2,785 medical device reports received by FDA give Abbott Ireland Diagnostics Division as the manufacturer of the device involved, 0% of the MAUDE database, from April 2019 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

878 reports arrived in the 12 months to August 2026, close to the 819 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98%) and injury (2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Alinity i STAT High Sensitive Troponin-I Reagent Kit	Immunoassay method, troponin subunit	401	147	0%
Alinity I Free T4 Reagent Kit	Radioimmunoassay, free thyroxine	374	125	0%
ARCHITECT STAT High Sensitive Troponin-I	Immunoassay method, troponin subunit	247	59	0%
Alinity i Total B-hCG Reagent Kit	System, test, human chorionic gonadotropin	207	74	0%
Architect Total B-Hcg Reagent Kit	System, test, human chorionic gonadotropin	125	0	0%
ARCHITECT TOTAL B-hCG	System, test, human chorionic gonadotropin	69	51	0%
ARCHITECT Anti-HBs	Test, hepatitis b (b antigen, b surface antigen, be antigen)	37	15	0%
Architect Tsh	Radioimmunoassay, thyroid-stimulating hormone	20	15	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
MMI	Immunoassay method, troponin subunit	768	27.6%
CEC	Radioimmunoassay, free thyroxine	524	18.8%
LOM	Test, hepatitis b (b antigen, b surface antigen, be antigen)	418	15%
DHA	System, test, human chorionic gonadotropin	401	14.4%
JLW	Radioimmunoassay, thyroid-stimulating hormone	161	5.8%
LFZ	Enzyme linked immunoabsorbent assay, cytomegalovirus	72	2.6%
JGJ	Photometric method, magnesium	54	1.9%
MTF	Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer	39	1.4%
QHM	Serology tests used for infectious disease screening of blood and plasma donations	35	1.3%
CJY	Azo dye, calcium	25	0.9%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%0

Injury2%56

Malfunction98%2,729

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Abbott Ireland Diagnostics Division reports

How many FDA device reports name Abbott Ireland Diagnostics Division as manufacturer?

2,785 reports through August 2026, 878 of them in the latest 12 months.

Which of its brands appear most often?

Alinity i STAT High Sensitive Troponin-I Reagent Kit (401), Alinity I Free T4 Reagent Kit (374), ARCHITECT STAT High Sensitive Troponin-I (247), Alinity i Total B-hCG Reagent Kit (207) and Architect Total B-Hcg Reagent Kit (125).

Which device types does it report on?

immunoassay method, troponin subunit (27.6%), radioimmunoassay, free thyroxine (18.8%), test, hepatitis b (b antigen, b surface antigen, be antigen) (15%) and system, test, human chorionic gonadotropin (14.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.