cobas b 123 <3> POC system 5122279001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630036943), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2018Low Test Results; Low Test Results

  THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR HEMOGLOBIN AND HCT ON A COBAS B 123 INSTRUMENT COMPARED TO THE BECKMAN COULTER HEMATOLOGY ANALYZER. THE PATIENT WAS INITIALLY TESTED ON THE B 123 INSTRUMENT WITH A HEMOGLOBIN RESULT OF 4.1 G/DL AND AN HCT OF 16%. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PHYSICIAN TREATED THE PATIENT WITH A TRANSFUSION OF 2 UNITS OF ERYTHROCYTE CONCENTRATES. THE PATIENT WAS TESTED BY THE BECKMAN COULTER ANALYZER AND THE HEMOGLOBIN RESULT WAS 8.2 G/DL AND THE HCT WAS 24.9% SO THE TRANSFUSION WAS NOT NECESSARY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED DUE TO THE TRANSFUSION. THE SENSOR CARTRIDGE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. QC VALUES FOR HEMOGLOBIN WERE ACCEPTABLE. NO ALARMS WERE PRODUCED BY THE B 123 INSTRUMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7946657 ↗