Prostate-specific antigen (psa) for management of prostate cancers: medical device reports filed with FDA

653 reports carry this product code, 1996–2026; 17 brands with a page.

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.

653
reports with this product code: 0% of all MAUDE reports; 8
reports, 12 months to August 2026: 14 in the 12 months before; 85.1%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code LTJ is FDA's classification for "Prostate-specific antigen (psa) for management of prostate cancers" (immunology panel), a class 2 device. 653 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to July 2026.

8 reports arrived in the 12 months to August 2026, down 43% from 14 in 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 (85.1%), injury (10.6%) and other (4.1%). 17 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Access 2 Immunoassay System	30	0	0%	79.6%
Analytical E Module	19	0	0%	99.6%
Elecsys 2010 Disk	10	0	0%	99.2%
Unicel Dxi 800 Access Immunoassay System	6	0	0%	89.5%
Abbott Axsym System	5	0	0%	54.4%
Immulite 2000 Xpi	5	10	0%	99.8%
Unicel Dxl800 Access Immunoassay System	5	0	0%	89.6%
Unicel Dxi 600 Access Immunoassay System	3	0	0%	95.8%
Access Immunoassay System	2	0	0%	31%
Immulite 2000	2	0	0%	87.4%
Unicel Dxl 800 Access Immunoassay System	2	0	0%	66.5%
Architect I1000sr Analyzer	1	0	0.3%	95.8%
Cobas 8000 E602 Module	1	0	0%	99.5%
Deltec	1	4	3.6%	63.5%
Modular Analytics Core	1	0	0%	99.1%
UniCel DxC 600i SYNCHRON Access Clinical System	1	13	0%	89.6%
Vaxcel Pasv Picc	1	0	0.7%	86.4%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Beckman Coulter	108	16.5%
Abbott Ireland	45	6.9%
Roche Diagnostics	44	6.7%
Dade Behring	33	5.1%
Abbott Manufacturing	20	3.1%
Abbott Laboratories	10	1.5%
Siemens Healthcare Diagnostics	7	1.1%
Ortho-Clinical Diagnostics	6	0.9%
Abbott Ireland Diagnostics Division	3	0.5%
Biotronik	1	0.2%
Tosoh	1	0.2%

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 and report source

Event type

Death0.2%1

Injury10.6%69

Malfunction85.1%556

Other4.1%27

Not given0%0

Who filed

Manufacturer report98.3%642

Voluntary report0.8%5

User facility report0%0

Distributor report0.5%3

Not given0.5%3

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
High test results	230	35.2%
Low test results	196	30%
Incorrect or inadequate test results	131	20.1%
Incorrect, inadequate or imprecise result or readings	24	3.7%
Incorrect measurementthe device measured wrongly	21	3.2%
False negative result	14	2.1%
Non reproducible results	10	1.5%
False positive result	8	1.2%
Device displays incorrect message	5	0.8%
False reading from device non-compliance	5	0.8%
Calibration problem	3	0.5%
Low readingsreadings were too low	3	0.5%
Replace	3	0.5%
Defective devicethe device was defective	2	0.3%
Device issuea problem with the device	2	0.3%
Fracturea broken bone	2	0.3%
Hole in material	2	0.3%
Improper or incorrect procedure or method	2	0.3%
Leak/splashthe device leaked	2	0.3%
Nonstandard device	2	0.3%

Questions about prostate-specific antigen (psa) for management of prostate cancers reports

What is product code LTJ?

FDA's classification code for "Prostate-specific antigen (psa) for management of prostate cancers", class 2, reviewed by the immunology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

653 reports through August 2026, 8 of them in the latest 12 months.

Which brands appear most often?

Access 2 Immunoassay System (30), Analytical E Module (19), Elecsys 2010 Disk (10), Unicel Dxi 800 Access Immunoassay System (6) and Abbott Axsym System (5). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.