Rheumatoid Factors II 5480167190Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630927357), received between Feb 1, 2024 and Nov 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Low Test Results; Output Problem; Low Test Results; Output Problem

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH RHEUMATOID FACTORS II RF-II ON A COBAS 8000 C702 MODULE. THE CUSTOMER ALLEGED THE ANALYZER WAS NOT PERFORMING AUTOMATIC DILUTIONS AS EXPECTED. THE SAMPLE INITIALLY RESULTED IN A RHEUMATOID FACTOR VALUE OF 98 IU/ML. THE SAMPLE WAS THEN AUTOMATICALLY DILUTED 1:20 AND REPEATED, RESULTING IN A VALUE OF > 650 IU/ML. THE SAMPLE WAS REPEATED ON 24-OCT-2024, RESULTING IN A RHEUMATOID FACTOR VALUE OF 104 IU/ML. THE SAMPLE AUTOMATICALLY REPEATED AT A DECREASED SAMPLE VOLUME ON (B)(6) 2024, RESULTING IN A VALUE OF 549 IU/ML. THE SAMPLE WAS REPEATED TWO ADDITIONAL TIMES ON (B)(6)2024, RESULTING IN VALUES OF 101 IU/ML AND 101 IU/ML. THE SAMPLE WAS REPEATED ON 25-OCT-2024, RESULTING IN A RHEUMATOID FACTOR VALUE OF 106 IU/ML. THE SAMPLE WAS REPEATED ON 29-OCT-2024, RESULTING IN A RHEUMATOID FACTOR VALUE OF 109 IU/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749508 ↗
• MalfunctionOct 3, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RF-II RHEUMATOID FACTORS II RESULTS FOR 1 PATIENT ON A COBAS 8000 COBAS C 701 MODULE. ON (B)(6) 2024, THE INITIAL SERUM SAMPLE RESULT WAS 23.4 IU/ML WITH FLAG. THE SAMPLE WAS REPEATED AND THE RESULT WAS 0.00 IU/ML. A 1:20 DILUTION WAS MADE OF THE SAMPLE AND TESTED AND THE RESULT WAS 63.3 IU/ML. ON (B)(6) 2024, THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 6.7 IU/ML ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. A 1:5 DILUTION WAS MADE OF THE SAMPLE AND TESTED AND THE RESULT WAS 23.3 IU/ML. A 1:10 DILUTION WAS MADE OF THE SAMPLE AND TESTED AND THE RESULT WAS 20.2 IU/ML. THE SAMPLE WAS ALSO TESTED ON ANOTHER STANDBY REAGENT PACK OF THE SAME LOT AND THE RESULT WAS 2.4 IU/ML ACCOMPANIED BY A FLAG INDICATING THE VALUE IS ABOVE THE LINEARITY/MEASURING RANGE OF THE ASSAY. TWO 1:5 DILUTIONS WERE MADE OF THE SAMPLE AND TESTED AND BOTH RESULTS WERE 0.0 IU/ML. ON (B)(6) 2024, ANOTHER PATIENT SERUM SAMPLE WAS TESTED AND THE RF-II RESULT WAS 6.1 IU/ML. A 1:5 DILUTION WAS MADE OF THE SAMPLE AND TESTED AND THE RESULT WAS 18.0 IU/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363026 ↗
• MalfunctionFeb 1, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE RHEUMATOID FACTOR RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 8000 C702 MODULE. THE INITIAL RESULT ANALYZED ON A SAMPLE ALIQUOT FROM COBAS C8100 PREANALYTICAL SYSTEM WAS 78 IU/ML ALL REANALYSIS WAS DONE ON THE PRIMARY TUBE. THE FIRST REPEAT RESULT WAS 66.9 IU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH DECREASED SAMPLE VOLUME WAS 409 IU/ML WITH A DATA FLAG. THE THIRD REPEAT RESULT WITH A 1:50 DILUTION WAS 4525 IU/ML. THE DISCREPANCY WAS IMMEDIATELY DISCOVERED SINCE THE PATIENT'S PREVIOUS MEASURED RESULT WAS 3883 IU/ML. THE ERRONEOUS RESULT WAS NOT RELEASED FROM THE LAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624388 ↗