System, test, automated blood grouping and antibody: medical device reports filed with FDA

10,406 reports carry this product code, 1994–2026; 13 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.

10,406
reports with this product code: 0% of all MAUDE reports; 50
reports, 12 months to August 2026: 74 in the 12 months before; 96.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KSZ is FDA's classification for "System, test, automated blood grouping and antibody" (hematology panel), a class 2 device. 10,406 medical device reports carry this product code, 0% of the MAUDE database, from March 1994 to August 2026.

50 reports arrived in the 12 months to August 2026, down 32% from 74 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 (96.2%), other (2.5%) and injury (1%). 13 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	Classified as death	Classified as malfunction
Ortho Provue	1,437	0%	97.3%
Galileo Echo	896	0%	100%
Galileo	660	0.1%	97.6%
Capture-R Ready-Screen 3	491	0%	100%
0 8% Resolve Panel A	373	0%	88.5%
Ortho Provue Analyzer	332	0%	97.7%
Echo	249	0%	100%
Galileo Neo	177	0%	100%
0 8% Surgiscreen	157	0%	71.7%
Tango Optimo	156	0%	100%
0 8% Selectogen	151	0%	83.1%
Mts A/B/D Monoclonal And Reverse Grouping Card	144	0%	98.4%
Ortho Summit Sample Handling System	1	0%	69.4%

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
Immucor	3,926	37.7%
Micro Typing Systems	1,468	14.1%
Bio-Rad Medical Diagnostics	1,083	10.4%
Ortho-Clinical Diagnostics	1,080	10.4%
Ortho Clinical Diagnostics	1,072	10.3%
Microtyping Systems	1,014	9.7%
Olympus Optical	8	0.1%
Beckman Coulter	2	0%
Hamilton Bonaduz	1	0%
Nellcor Puritan Bennett	1	0%

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

Death0.1%6

Injury1%100

Malfunction96.2%10,015

Other2.5%257

Not given0.3%28

Who filed

Manufacturer report92.4%9,619

Voluntary report0.3%33

User facility report0%0

Distributor report7.2%749

Not given0%5

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

Device problems coded

Device problem (FDA code)	Reports	Share
False negative result	5,504	52.9%
Incorrect or inadequate test results	1,358	13.1%
False positive result	1,128	10.8%
Incorrect, inadequate or imprecise result or readings	542	5.2%
Fluid/blood leak	422	4.1%
Other (for use when an appropriate device code cannot be identified)	329	3.2%
Device operates differently than expectedthe device behaved unexpectedly	211	2%
Display difficult to read	105	1%
Defective devicethe device was defective	100	1%
Improper or incorrect procedure or method	85	0.8%
Device issuea problem with the device	74	0.7%
Leak/splashthe device leaked	73	0.7%
Unexpected therapeutic results	72	0.7%
Overfill	70	0.7%
Bent	61	0.6%
Malfunction	61	0.6%
Contamination	58	0.6%
Device displays incorrect message	58	0.6%
Defective component	56	0.5%
False reading from device non-compliance	56	0.5%

Questions about system, test, automated blood grouping and antibody reports

What is product code KSZ?

FDA's classification code for "System, test, automated blood grouping and antibody", class 2, reviewed by the hematology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

10,406 reports through August 2026, 50 of them in the latest 12 months.

Which brands appear most often?

Ortho Provue (1,437), Galileo Echo (896), Galileo (660), Capture-R Ready-Screen 3 (491) and 0 8% Resolve Panel A (373). 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.