Separator, automated, blood cell, diagnostic: medical device reports filed with FDA

6,581 reports carry this product code, 1993–2026; 6 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.

6,581
reports with this product code: 0% of all MAUDE reports; 155
reports, 12 months to August 2026: 341 in the 12 months before; 77.2%
classified as malfunction: 62.3% across all reports; 4%
classified as death, as reported: 0.9% across all reports

Product code GKT is FDA's classification for "Separator, automated, blood cell, diagnostic" (hematology panel), a class 2 device. 6,581 medical device reports carry this product code, 0% of the MAUDE database, from May 1993 to August 2026.

155 reports arrived in the 12 months to August 2026, down 55% from 341 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 (77.2%), injury (14.1%) and death (4%). 6 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
Trima Accel	4,240	89	0.2%	93.1%
Spectra Optia	397	70	4.9%	56.3%
Cobe Spectra Blood Collection	287	0	4.2%	18.8%
Pcs2 Plasma Collection System	264	0	28.8%	59.1%
Trima Accel Enhanced Plt Pls Rbc Set	49	0	0%	79%
Baxter	1	3	3.8%	54.2%

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
Terumo Bct	5,154	78.3%
Haemonetics	545	8.3%
Baxter Healthcare	376	5.7%
Terumo	3	0%
Beckman Coulter	2	0%
Gambro Healthcare	2	0%
Fresenius USA	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

Death4%266

Injury14.1%931

Malfunction77.2%5,082

Other1.3%86

Not given3.3%216

Who filed

Manufacturer report97.4%6,413

Voluntary report1.4%91

User facility report0%0

Distributor report0%1

Not given1.2%76

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

Device problems coded

Device problem (FDA code)	Reports	Share
High test results	1,333	20.3%
Insufficient device problem information	1,173	17.8%
Device operates differently than expectedthe device behaved unexpectedly	505	7.7%
High readingsreadings were too high	258	3.9%
Mechanical problema mechanical problem	165	2.5%
Device slipped	150	2.3%
Device displays incorrect message	143	2.2%
Improper or incorrect procedure or method	142	2.2%
Disposable	124	1.9%
Fluid/blood leak	107	1.6%
Contamination of device ingredient or reagent	106	1.6%
Reactiona reaction, type not specified	91	1.4%
Thermal decomposition of device	89	1.4%
Air leak	84	1.3%
Incorrect or inadequate test results	82	1.2%
Incorrect, inadequate or imprecise result or readings	82	1.2%
Inaccurate flow rate	77	1.2%
Device handling problem	76	1.2%
Temperature problem	67	1%
Patient-device incompatibilitythe device did not suit the patient	64	1%

Questions about separator, automated, blood cell, diagnostic reports

What is product code GKT?

FDA's classification code for "Separator, automated, blood cell, diagnostic", class 2, reviewed by the hematology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,581 reports through August 2026, 155 of them in the latest 12 months.

Which brands appear most often?

Trima Accel (4,240), Spectra Optia (397), Cobe Spectra Blood Collection (287), Pcs2 Plasma Collection System (264) and Trima Accel Enhanced Plt Pls Rbc Set (49). 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.