Automated Blood Coagulation Analyzer CA-600 series CA-660 CK978289Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987562425716), received between Aug 30, 2018 and Aug 30, 2018 — classified as 1 injury.

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OPERATOR IN THE UNITED STATES ANALYZED A SAMPLE, COLLECTED FROM AN OUTPATIENT, FOR A PROTHROMBIN TIME (PT). A "NO COAGULATION" RESULT WAS GENERATED. THE SAMPLE WAS REPEATED FOR AN EXTENDED PT (PTX), WITH A RESULT OF "NO COAGULATION". THE OPERATOR REPORTED THE RESULT OF "NO COAGULATION" TO THE CLINICIAN. THE CLINICIAN QUESTIONED THE RESULT, HOWEVER THE PATIENT HAD ALREADY BEEN TREATED WITH VITAMIN K. THE SAME DAY, A NEW SAMPLE FROM THE SAME PATIENT WAS COLLECTED AND ANALYZED ON THE SAME ANALYZER AND THE RESULTS GENERATED WERE NORMAL. THE LAB TECH RE-CENTRIFUGED AND RE-ANALYZED THE ORIGINAL SAMPLE. THIS TIME, NORMAL RESULTS WERE GENERATED. THE USER CONFIRMED WITH THE CLINICIAN THAT THERE WAS NO HARM TO THE PATIENT DUE TO RECEIPT OF VITAMIN K.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7834447 ↗