Analyzer, chemistry (sequential multiple, continuous flow) clinical use: medical device reports filed with FDA

354 reports carry this product code, 1993–2015; 9 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.

354
reports with this product code: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 74.6%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code JJC is FDA's classification for "Analyzer, chemistry (sequential multiple, continuous flow) clinical use" (clinical Chemistry panel), a class 1 device. 354 medical device reports carry this product code, 0% of the MAUDE database, from July 1993 to August 2015.

0 reports arrived in the 12 months to August 2026, and none 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 (74.6%), other (15.8%) and injury (5.6%). 9 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
Dimension	16	40	0.1%	98.5%
Unicel Dxc 800 Pro Synchron Chemistry Analyzer	14	0	0%	95.2%
Synchron Lxi 725 Clinical System	12	0	0%	97.3%
Unicel Dxc 600 Pro Synchron Chemistry Analyzer	5	0	0%	87%
UniCel DxC 600i SYNCHRON Access Clinical System	5	13	0%	89.6%
Access 2 Immunoassay System	4	0	0%	79.6%
Vitros 5 1 Fs Chemistry System	4	0	0%	99.4%
Synchron Lx I 725 Clinical System	2	0	0%	73.1%
Unicel Dxl 800 Access Immunoassay System	2	0	0%	66.5%

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	127	35.9%
Abbott Manufacturing	16	4.5%
Tosoh	5	1.4%
Dade Behring	4	1.1%
Roche Diagnostics	2	0.6%
Abbott	1	0.3%
Abbott Point Of Care	1	0.3%
Bayer Healthcare	1	0.3%

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

Death0.6%2

Injury5.6%20

Malfunction74.6%264

Other15.8%56

Not given3.4%12

Who filed

Manufacturer report80.8%286

Voluntary report12.1%43

User facility report0%0

Distributor report2.5%9

Not given4.5%16

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

Device problems coded

Device problem (FDA code)	Reports	Share
Incorrect or inadequate test results	79	22.3%
Low test results	67	18.9%
High test results	62	17.5%
Leak/splashthe device leaked	17	4.8%
Inadequate service	14	4%
Computer software problema software problem	10	2.8%
False positive result	10	2.8%
False reading from device non-compliance	10	2.8%
Fluid/blood leak	10	2.8%
Incorrect, inadequate or imprecise result or readings	10	2.8%
Calibration error	9	2.5%
Failure to calibrate	9	2.5%
Repair	8	2.3%
Replace	7	2%
Other (for use when an appropriate device code cannot be identified)	5	1.4%
Crackthe device cracked	4	1.1%
Design/structure problem	4	1.1%
Device displays incorrect message	4	1.1%
Malfunction	4	1.1%
Device alarm system	3	0.8%

Questions about analyzer, chemistry (sequential multiple, continuous flow) clinical use reports

What is product code JJC?

FDA's classification code for "Analyzer, chemistry (sequential multiple, continuous flow) clinical use", class 1, reviewed by the clinical Chemistry panel. Every device report carries the product code of the device involved.

How many reports carry this code?

354 reports through August 2026, 0 of them in the latest 12 months.

Which brands appear most often?

Dimension (16), Unicel Dxc 800 Pro Synchron Chemistry Analyzer (14), Synchron Lxi 725 Clinical System (12), Unicel Dxc 600 Pro Synchron Chemistry Analyzer (5) and UniCel DxC 600i SYNCHRON Access Clinical 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.