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FDA product code JQW · class 1 · Clinical Chemistry

Station, pipetting and diluting, for clinical use: medical device reports filed with FDA

363 reports carry this product code, 1996–2026; 1 brands with a page.

363
reports with this product code
0% of all MAUDE reports
14
reports, 12 months to August 2026
17 in the 12 months before
81.8%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

Product code JQW is FDA's classification for "Station, pipetting and diluting, for clinical use" (clinical Chemistry panel), a class 1 device. 363 medical device reports carry this product code, 0% of the MAUDE database, from December 1996 to August 2026.

14 reports arrived in the 12 months to August 2026, down 18% from 17 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 (81.8%), other (9.4%) and injury (7.7%). 1 brand name 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

BrandReportsLatest 12 monthsClassified as deathClassified as malfunction
Ortho Summit Sample Handling System600%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)ReportsShare
Becton Dickinson And Bd Biosciences14840.8%
Abbott Manufacturing4913.5%
Abbott Molecular318.5%
Hamilton Bonaduz71.9%
Roche Molecular Systems - Branchburg41.1%
Agilent Technologies30.8%
Beckman Coulter10.3%
Becton Dickinson Infusion Therapy Systems10.3%
Immucor10.3%
Micro Typing Systems10.3%

Reports by month, five years

048Sep 2021: 4Oct 2021: 5Nov 2021: 4Dec 2021: 12022Jan 2022: 0Feb 2022: 6Mar 2022: 3Apr 2022: 3May 2022: 8Jun 2022: 4Jul 2022: 1Aug 2022: 3Sep 2022: 4Oct 2022: 8Nov 2022: 2Dec 2022: 22023Jan 2023: 5Feb 2023: 1Mar 2023: 5Apr 2023: 3May 2023: 1Jun 2023: 3Jul 2023: 5Aug 2023: 3Sep 2023: 4Oct 2023: 2Nov 2023: 2Dec 2023: 22024Jan 2024: 1Feb 2024: 1Mar 2024: 0Apr 2024: 0May 2024: 1Jun 2024: 0Jul 2024: 5Aug 2024: 1Sep 2024: 0Oct 2024: 0Nov 2024: 1Dec 2024: 52025Jan 2025: 1Feb 2025: 0Mar 2025: 1Apr 2025: 3May 2025: 0Jun 2025: 3Jul 2025: 1Aug 2025: 2Sep 2025: 0Oct 2025: 1Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 1Apr 2026: 1May 2026: 1Jun 2026: 2Jul 2026: 3Aug 2026: 5

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%0
Injury7.7%28
Malfunction81.8%297
Other9.4%34
Not given1.1%4

Who filed

Manufacturer report93.7%340
Voluntary report0.3%1
User facility report0%0
Distributor report5.8%21
Not given0.3%1

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

Device problems coded

Device problem (FDA code)ReportsShare
Incorrect, inadequate or imprecise result or readings6317.4%
Fluid/blood leak5515.2%
Contamination4712.9%
Display difficult to read123.3%
Malfunction113%
Material deformation113%
Other (for use when an appropriate device code cannot be identified)102.8%
Device operates differently than expectedthe device behaved unexpectedly92.5%
Smoking92.5%
Computer software problema software problem82.2%
False positive result82.2%
Incorrect or inadequate test results82.2%
Device handling problem71.9%
Error or warning message, failure to produce71.9%
Improper or incorrect procedure or method71.9%
Inaccurate delivery71.9%
Component falling61.7%
Crackthe device cracked61.7%
Device fell61.7%
Leak/splashthe device leaked61.7%

Questions about station, pipetting and diluting, for clinical use reports

What is product code JQW?

FDA's classification code for "Station, pipetting and diluting, for 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?

363 reports through August 2026, 14 of them in the latest 12 months.

Which brands appear most often?

Ortho Summit Sample Handling System (6). 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.