COULTER DxH Diluent 628017Recalls & reported problems
Beckman Coulter, Inc. · COULTER DxH Diluent · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590233686), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 10, 2025Class IIOpen, Classified
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
Z-1221-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT WHILE SIGNING REAGENT DELIVERY RECEIPT, THE DELIVERY DRIVER FROM MOVIANTO ACCIDENTALLY DROPPED A PALLET OF DXH DILUENT 10L ON THEIR (CUSTOMER¿S) FOOT. THE CUSTOMER WENT TO URGENT CARE WHERE AN X-RAY AND PHYSICAL ASSESSMENT WERE PERFORMED. THE X-RAY INDICATED NO BROKEN BONES, BUT POSSIBLE ¿LIGAMENT AND TENDON DAMAGE¿ WAS DOCUMENTED. THE ATTENDING PHYSICIAN PRESCRIBED ANTI-INFLAMMATORY AND PAIN MEDICATION AND INSTRUCTED THE CUSTOMER SEE HER GP (GENERAL PRACTITIONER) FOR ANY CONCERNS OR IF PAIN CONTINUES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9406329 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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