Automated Blood Coagulation Analyzer CA-600 series CA-620 BR142626Recalls & reported problems
Sysmex Corporation · Automated Blood Coagulation Analyzer CA-620 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987562425686), received between Dec 9, 2019 and Dec 9, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence 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 9, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
A SAMPLE WAS ANALYZED AND GENERATED ASTERISKS WITH A "NO COAGULATION" FLAG INSTEAD OF A NUMERIC PROTIME (PT) RESULT. THE USER REPORTED THE PT RESULT AS "NO COAGULATION" TO THE PHYSICIAN. THE PATIENT WAS ADMINISTERED 5MG VITAMIN K (MEPHYTON). NO HARM TO THE PATIENT DUE TO THE ADMINISTRATION OF VITAMIN K WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9440312 ↗
Other SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES devices
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- TEG5000 HEMOSTASIS ANALYZER 07-022Haemonetics Corporation · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall2 reports
- STA Satellite® 58104Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall1 report
- ACL ELITE 00000880311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311Instrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE 00000880311RInstrumentation Laboratory Company · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- Hemochron Whole Blood Microcoagulation System ELITEAccriva Diagnostics Holdings, Inc. · System, Multipurpose For In Vitro Coagulation Studies2 deaths13 reports
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
- 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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